ThermaCare HeatWraps ThermaCare HeatWraps - Neck, Wrist & Shoulder (UDI 00305733015025)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00305733015025), received between Dec 18, 2018 and Sep 25, 2022 — classified as 1 death, 22 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 06-SEP-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A 66-YEAR-OLD FEMALE WHO USED A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP. MEDICAL HISTORY INCLUDED HIGH CHOLESTEROL. ALLERGIES INCLUDED SODIUM PENTOTHAL, SULFONAMIDES, PENICILLIN, AND SWORDFISH. CONCOMITANT PRODUCTS INCLUDED AN UNSPECIFIED MEDICATION FOR HIGH CHOLESTEROL. ON (B)(6) 2022, THE CONSUMER APPLIED A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP DIRECTLY TO HER SKIN ON HER LEFT THIGH. SHE WORE LOOSE FITTING JOGGING PANTS OVER THE HEAT WRAP. APPROXIMATELY 4 HOURS AFTER APPLICATION, THE HEAT WRAP STARTED TO FALL OFF. THE EDGES WERE PEELED BACK AND WERE NO LONGER STICKING TO HER SKIN. SHE WAS AT A STORE AND WENT TO THE BATHROOM TO SEE IF SHE COULD HELP MAKE IT STICK. SHE REMOVED HER CLOTHING AND NOTED SKIN REDNESS AT THE APPLICATION SITE. SHE NOTED THE HEAT WRAP BURNED HER IN 3 DIFFERENT PLACES. THE REDNESS WAS IN THE SHAPE OF THE HEAT WRAP AND WAS ONLY AT THE APPLICATION SITE. SHE DENIED PAIN OR DISCOMFORT. AFTER SHE SAW THE REDNESS, SHE DID NOT FEEL COMFORTABLE IN TRYING TO GET THE HEAT WRAP TO STICK. SHE THREW THE PATCH AWAY AND WENT HOME. ONCE SHE ARRIVED AT HOME, SHE APPL

  Patient problems: Burn(s); Erythema

  MAUDE report 15481876 ↗
• MalfunctionJul 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES FROM A CONSUMER VIA TELEPHONE REGARDING A FEMALE (AGE NOT PROVIDED) CONSUMER WHO USED A THERMACARE NECK/SHOULDER/WRIST 8HR. MEDICAL HISTORY INCLUDED PRIOR USE OF THERMACARE LOWER BACK AND HIP WITHOUT EVENT. FURTHER MEDICAL HISTORY AND USE OF CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE NECK/SHOULDER/WRIST 8HR TO AN UNSPECIFIED LOCATION FOR AN UNKNOWN INDICATION. AFTER 4 HOURS OF USE, THE DEVICE BURNT HER BADLY. THE CONSUMER NOTED THAT ONE OF THE BURNS TURNED INTO A BLISTER. THE CONSUMER NOTED THAT EVERY 15 TO 20 MINUTES THE DEVICE WOULD GET VERY HOT AND THEN IT WOULD COOL DOWN. THE CONSUMER DECLINED TO PROVIDE FURTHER INFORMATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15020414 ↗
• MalfunctionApr 15, 2022Excessive Heating; Excessive Heating

  ON 31-MAR-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A FEMALE (AGE NOT PROVIDED) WHO USED A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP. MEDICAL HISTORY INCLUDED PRIOR USE OF THERMACARE HEAT WRAPS WITHOUT ISSUE AND A FRACTURED NECK RESULTING IN PAIN. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP ACROSS HER SHOULDER AREA AROUND HER NECK AS IT LOOKED ON THE PACKAGING FOR PAIN. APPROXIMATELY 6.5 HOURS AFTER TOPICALLY APPLYING THE HEAT WRAP, THE CONSUMER NOTED THAT THE HEAT WRAP BECOME REALLY HOT AT ONE POINT. SHE THOUGHT IT WAS JUST A REACTION THAT HER BODY WAS GIVING HER, AND SHE DID NOT MIND UNTIL SHE FELT A VERY PAINFUL STING. SUBSEQUENTLY, SHE REMOVED THE PRODUCT. HER FRIEND, WHO WAS A HEALTH CARE PROFESSIONAL, LOOKED AT THE AREA BECAUSE THE CONSUMER COULD NOT SEE THE AREA WHERE IT WAS APPLIED. HER FRIEND CONFIRMED THAT SHE RECEIVED A BURN FROM THE PATCH AND THE AREAS SURROUNDING IT WERE VERY RED. THE CONSUMER DECLINED TO PROVIDE FURTHER INFORMATION.

  Patient problems: Burn(s); Erythema; Pain

  MAUDE report 14120444 ↗
• InjuryMar 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 23-FEB-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A FEMALE CONSUMER (AGE NOT REPORTED) WHO WAS USING THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP (LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED) TO HER ARM AND CHEST FOR AN UNSPECIFIED INDICATION. ON AN UNSPECIFIED DATE, AFTER USING THE PRODUCT, THE CONSUMER COULD FEEL BURNING. SHE WORE THE PRODUCT FOR 5 TO 8 MINUTES AND SHE THOUGHT THAT THE ADHESIVE HAD BURNT HER. THE NEXT DAY SHE WOKE UP AND HAD BRUISES WHERE THE PATCHES WERE. NO ADDITIONAL INFORMATION WAS PROVIDED AS THE REPORTER DECLINED FURTHER PARTICIPATION.

  Patient problems: Bruise/Contusion; Burn(s)

  MAUDE report 13806849 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 17-FEB-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) WHO WAS USING THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAPS. MEDICAL HISTORY AND USE OF CONCOMITANT PRODUCTS WERE UNKNOWN. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP (EXPIRATION DATE: 31-MAY-2024; LOT NUMBER: GA0032). THE LOCATION AND DURATION OF APPLICATION WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, AFTER TOPICALLY APPLYING A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP THE CONSUMER NOTED IT GAVE HER BURN BLISTERS ON HER SKIN. FOR TREATMENT SHE HAD BEEN PUTTING OINTMENT (UNSPECIFIED) ON THE BLISTERS UNTIL THEY HEALED UP. NO ADDITIONAL INFORMATION WAS PROVIDED AS THE CONSUMER REFUSED FURTHER PARTICIPATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 13795057 ↗
• InjuryMar 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 09-FEB-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A (B)(6) FEMALE PATIENT WHO USED THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP. ON 16-FEB-2022, ADDITIONAL INFORMATION WAS PROVIDED BY THE CONSUMER. MEDICAL HISTORY INCLUDED TYPE II DIABETES, ARTHRITIS, HIGH CHOLESTEROL, AND PRIOR USE OF THERMACARE FOR YEARS WITHOUT ISSUE. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN. ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP (EXPIRATION DATE AND LOT NUMBER NOT PROVIDED) DIRECTLY TO THE SKIN OF HER NECK FOR ARTHRITIS. ON (B)(6) 2022, WITHIN AN HOUR OF TAKING THE PATCH OFF (AFTER WEARING IT FOR 6 HOURS), SHE HAD BURNS AND BLISTERING ON HER NECK. HER NEIGHBOR CAME OVER AFTER SHE MENTIONED IT BOTHERED HER NECK. WHEN SHE TOOK THE PRODUCT OFF THE NEIGHBOR NOTICED THE AREA WAS RED AND BLISTERED. ON UNSPECIFIED DATES, THE CONSUMER SAW HER DOCTOR. THE DOCTOR APPLIED SILVER SULFADIAZINE CREAM AND BANDAGED THE AREA. THE DOCTOR ALSO WROTE A PRESCRIPTION FOR THE SILVER SULFADIAZINE CREAM. DURING HER SECOND VISIT, THE LAST WEEK (RELATIVE TO (B)(6) 2022), THE DOCTOR TOLD HER TO KEEP THE AREA CLEAN, DRY,

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 13653169 ↗
• DeathFeb 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES FROM A CONSUMER VIA TELEPHONE REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) WHO WAS USING (B)(6)NECK/SHOULDER/WRIST 8HR HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED TOPICALLY APPLIED A (B)(6)NECK/SHOULDER/WRIST 8HR HEAT WRAP (EXPIRATION DATE 18-MAR-2021; LOT NUMBER UNKNOWN) FOR AN UNSPECIFIED INDICATION. ON (B)(6)-2022, UPDATED INFORMATION WAS RECEIVED FROM A CONSUMER. ON AN UNSPECIFIED DATE, THE CONSUMER BOUGHT AN EXPIRED (B)(6) NECK/SHOULDER/WRIST 8HR HEAT WRAP. THE PRODUCT DID NOT HEAT. ON (B)(6) 2022, THE CONSUMER WAS NOTED TO HAVE DIED. THE CAUSE OF DEATH AND DATE OF DEATH WERE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED AS FURTHER PARTICIPATION IN THE ADVERSE EVENT REPORTING PROCESS WAS DECLINED.

  Patient problems: Insufficient Information

  MAUDE report 13509734 ↗
• InjuryFeb 9, 2022Use of Device Problem; Temperature Problem; Use of Device Problem; Temperature Problem

  ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6) MALE WHO WAS USING A THERMACARE NECK, SHOULDER, WRIST 8HR HEAT WRAP. MEDICAL HISTORY INCLUDED DIABETES, HYPERTENSION, AND PAIN. CONCOMITANT PRODUCTS INCLUDED METFORMIN AND AN UNSPECIFIED MEDICATION FOR HYPERTENSION. ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE NECK, SHOULDER, WRIST 8HR (LOT NUMBER: 0W7747; EXPIRATION DATE SEP-2022) HEAT WRAP TO HIS LEFT LOWER BACK FOR PAIN. AFTER 2 HOURS OF APPLYING THE PRODUCT, THE CONSUMER TOOK IT OFF BECAUSE HE DID NOT FEEL HEAT. HE NOTED IT DID NOT HEAT UP AND IT DID NOT ALLEVIATE HIS PAIN. HE DID "SOME MOVING AROUND" WHICH TRIGGERED THE PAIN. HE THEN TURNED TO THE METHOD OF HEATING UP RICE IN A SOCK VIA A MICROWAVE TO BRING COMFORT TO THE PAIN. HE FELT PAIN AT THE APPLICATION SITE OF THE PRODUCT AND LOOKED INTO THE MIRROR. HE THEN SAW BLISTERS AT THE APPLICATION SITE. ON AN UNSPECIFIED DATE, THE CONSUMER CALLED HIS DOCTOR AND WAS ADVISED TO TAKE IBUPROFEN. HE WAS LOSING SLEEP BECAUSE OF THE PAIN. HE DID NOT HAVE A WAY TO GET TO THE DOCTOR. IT WAS THE FIRST AND THE LAST TIME HE USED THE PRODUCT. THE CONSUMER NOTED THAT IT H

  Patient problems: Pain; Partial thickness (Second Degree) Burn; Sleep Dysfunction

  MAUDE report 13498684 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A (B)(6) FEMALE WHO WAS USING THERMACARE NECK/SHOULDER/WRIST 8HR. MEDICAL HISTORY INCLUDED SEASONAL ALLERGIES, ARTHRITIS, DIABETES, ACID REFLUX, AND A KIDNEY TRANSPLANT IN 2018. CONCOMITANT PRODUCTS INCLUDED PROGRAFF (TACROLIMUS), MYCOPHENOLATE, VITAMIN D, VITAMIN B12, MULTIVITAMIN, AND OMEPRAZOLE. ON (B)(6) 2021, THE CONSUMER STARTED TREATMENT WITH THERMACARE NECK/SHOULDER/WRIST 8HR (LOT NUMBER LOT EH5503; EXPIRATION DATE 29-FEB-2024) APPLIED TOPICALLY FOR AN UNSPECIFIED INDICATION. AFTER APPLYING THE PRODUCT FOR 8 HOURS, SHE EXPERIENCED HAVING BLISTERS. IT WAS CLARIFIED AS 2 BLISTERS ON HER NECK. ONE BLISTER WAS SLIGHTLY LARGER THAN A QUARTER AND THE OTHER ONE WAS SMALLER. THEY WERE BUBBLE-LIKE IN APPEARANCE. THE CONSUMER DENIED APPLYING ADDITIONAL HEAT OR COVERINGS OVER THE TOP OF THE HEAT WRAP. SHE NO LONGER WAS ABLE TO USE THE WRAP LONGER THAN 8 HOURS. SHE WAS IN SEVERE PAIN. SHE WAS UNSURE IF SHE COULD DO HER JOB DUE TO THE PAIN FROM THE BURNS. ONE BLISTER OPENED IMMEDIATELY, AND THE OTHER BLISTER OPENED UP LATER THAT NIGHT. THE AREA WAS VERY RED, IRRITATED, AND PAINFUL. FOR TREATMENT

  Patient problems: Pain; Partial thickness (Second Degree) Burn

  MAUDE report 13112899 ↗
• InjuryNov 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 26-OCT-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES VIA TELEPHONE WAS RECEIVED REGARDING A FEMALE CONSUMER (AGE NOT REPORTED) WHO WAS USING THERMACARE NECK/SHOULDER/WRIST 8HR. MEDICAL HISTORY INCLUDED PRIOR USE OF THERMACARE HEAT WRAPS WITHOUT ISSUE. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE APPROXIMATELY ON (B)(6) 2021 OR THE (B)(6) 2021, THE CONSUMER APPLIED A USING THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP TO HER NECK FOR AN UNSPECIFIED INDICATION. ON AN UNSPECIFIED DATE APPROXIMATELY ON (B)(6) 2021 OR THE (B)(6) 2021, AFTER 12 TO 15 MINUTES OF DEVICE APPLICATION, THE CONSUMER WENT TO THE BATHROOM AND LOOKED IN THE MIRROR. HER NECK WAS RED AND SHE WAS BURNED. THE NEXT MORNING, "THEY WERE PUFFY SCARS". ADDITIONAL INFORMATION WAS NOT PROVIDED AS THE REPORTER DECLINED FURTHER PARTICIPATION IN THE ADVERSE EVENT PROCESS.

  Patient problems: Erythema; Scar Tissue; Superficial (First Degree) Burn; Swelling/ Edema

  MAUDE report 12844960 ↗
• InjuryAug 11, 2021Off-Label Use; Off-Label Use

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6) FEMALE WHO USED THERMACARE NECK/SHOULDER/WRIST 8HR 3CT (LOT NUMBER: "W92738N", EXPIRATION DATE: NOV-2021). MEDICAL HISTORY INCLUDED RHEUMATOID ARTHRITIS, HYPERTENSION, HIGH CHOLESTEROL, STIFF NECK, 5 CIGARETTE PER DAY SMOKER, AND PRIOR USE OF THERMACARE ON HER HIPS WITHOUT EVENT. CONCOMITANT PRODUCTS INCLUDED ATENOLOL, LOSARTAN, HYDROCHLOROTHIAZIDE, AND SIMVASTATIN. ON (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED THERMACARE NECK/SHOULDER/WRIST 8HR 3CT TO HER STIFF NECK APPROXIMATELY AT 9:30 TO 10:00 AM. THROUGHOUT THE DAY, SHE NOTICED THE WRAP WAS HOTTER THAN WHAT SHE WAS USED TO. SHE HAD PREVIOUSLY USED THE OTHER 2 WRAPS IN THE PACKAGE AND DID NOT HAVE ANY ISSUES WITH THEM. THE CONSUMER REMOVED THE PRODUCT AROUND 7:00 PM THE SAME NIGHT. SHE WAS NOT SURE HOW LONG SHE HAD LEFT THE PRODUCT ON BUT IT COULD HAVE BEEN BETWEEN 8-10 HOURS. APPROXIMATELY AT 7:00 PM THAT NIGHT, SHE REMOVED THE WRAP AND NOTICED THE BACK OF HER NECK WAS WET AND SHE HAD TINY BLISTERS ALL OVER THE APPLICATION SITE. SHE TOOK IT OFF AND HER "WHOLE NECK WAS BURNED AND BLISTERED." SHE SELF-TREATED HER SYMPT

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 12310621 ↗
• InjuryJul 15, 2021Off-Label Use; Off-Label Use

  ON 24-JUN-2021 A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6) YEAR-OLD FEMALE CONSUMER WHO WAS USING THERMACARE NECK/SHOULDER/WRIST 8HR 3CT HEAT WRAP. THE CONSUMER HAD NO KNOWN ALLERGIES AND WAS REPORTED TO BE HEALTHY. CONCOMITANT PRODUCTS INCLUDED TYLENOL (ACETAMINOPHEN). APPROXIMATELY ON (B)(6) 2020 AT 8AM, THE CONSUMER TOPICALLY APPLIED ONE THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP (LOT: EK9154, EXPIRATION DATE: 31-MAR-2024) TO THE BACK OF HER NECK ON HER SKIN FOR AN UNSPECIFIED INDICATION. THE CONSUMER DID NOT REMOVE THE HEAT WRAP UNTIL 10 PM THE SAME DAY, WHEN SHE TOOK A SHOWER. WHEN SHE REMOVED THE PRODUCT, SHE NOTICED HER NECK WAS RED, BURNING, AND HOT TO THE TOUCH. SHE WAS NOT 100% CLEAR WAS WHEN SHE DISCOVERED HER SYMPTOMS. AFTER HER SHOWER SHE LOOKED INTO THE MIRROR AND SAW THE REDNESS. THE REDNESS WAS THE SAME SIZE AS THE PRODUCT. ON (B)(6) 2021, SHE APPLIED ALOE VERA GEL TO THE AREA WHICH REDUCED THE REDNESS BY THE NEXT DAY. ALL OF HER SYMPTOMS RESOLVED WITHIN A COUPLE OF DAYS. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT SEEK OR ATTEMPT ANY OTHER TREATMENTS. SHE ONLY USED ONE OF THE HEAT WRAPS IN THE BOX.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 12174030 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, BRIDGES CONSUMER HEALTHCARE RECEIVED THE FOLLOWING REPORT FROM ANGELINI (B)(4). THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM (B)(6) RECEIVED ON (B)(6) 2021 FROM A PATIENT THROUGH DIAMED (DE1373). THIS CASE REPORT CONCERNS A FEMALE PATIENT WITH NO RELEVANT MEDICAL HISTORY, WHO APPLIED WAERMEAUFLAGEN F¿R NACKEN, SCHULTER UND HANDGELENK (THERMACARE NECK SHOULDER WRIST 12 HOUR) LOT NUMBER: UNKNOWN EXPIRY DATE: UNKNOWN) TOPICALLY ADMINISTERED FOR NECK PAIN. CONCOMITANT MEDICATIONS WERE NOT REPORTED. IN (B)(6) 2021, AFTER THERMACARE (WAERMEAUFLAGEN F¿R NACKEN, SCHULTER UND HANDGELENK) INITIATION, THE PATIENT EXPERIENCED BURN BLISTER, BURNING SENSATION AND HEADACHE. AFTER USE OF NO MORE THAN 12 HOURS THE PATIENT SUFFERED A BURNING SENSATION, HEADACHE AND BURN BLISTERS. THE PATIENT REPORTED THAT THREE DAYS LATER THE BURNING SENSATION WAS STILL PRESENT AND THAT SHE STILL EXPERIENCED PAIN. THE REPORT ALSO INCLUDED PICTURES OF THE BURN MARKS TAKEN ON (B)(6) 2021, ON (B)(6) 2021 AND ON (B)(6) 2021. OUTCOME: BURN BLISTER : UNKNOWN, BURNING SENSATION : NOT RECOVERED/NOT RESOLVED, HEADACHE : UNKNOWN.

  Patient problems: Headache; Partial thickness (Second Degree) Burn; Skin Burning Sensation

  MAUDE report 11938873 ↗
• InjuryMay 20, 2021Excessive Heating; Excessive Heating

  ON (B)(6) 2021, A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6) FEMALE CONSUMER WHO USED THE THERMACARE NECK/SHOULDER/WRIST HEAT WRAP. MEDICAL HISTORY INCLUDED NECK AND SHOULDER TENSION, PRIOR USE OF THERMACARE PRODUCTS, AND AN INACTIVE THYROID. CONCOMITANT PRODUCTS INCLUDED SYNTHROID (LEVOTHYROXINE) TAKEN DAILY. ON (B)(6) 2021, THE CONSUMER APPLIED THE THERMACARE NECK/SHOULDER/WRIST HEAT WRAP (LOT NUMBER AND EXPIRATION DATE NOT PROVIDED) TO HER NECK AND SHOULDER AREA TO HELP RELIEVE TENSION IN HER NECK AND SHOULDERS. SHE WORE THE PRODUCT FOR APPROXIMATELY 7 HOURS WHILE SHE WAS AT WORK. WHEN SHE ARRIVED HOME, SHE REMOVED THE PRODUCT. ON (B)(6) 2021, AFTER THE CONSUMER WOKE UP, SHE TOOK A SHOWER AND WHILE IN THE SHOWER SHE NOTED PAINFUL OPEN AREAS TO THE APPLICATION SITE. SHE REPORTED THERE WERE OPEN SORES. IT WAS PAINFUL AND VERY SENSITIVE. FOR TREATMENT SHE APPLIED ALOE AND BURN RELIEF CREAM TO THE AFFECTED AREAS. SHE DID NOT SEEK A MEDICAL DOCTOR FOR HER SYMPTOMS. THE CONSUMER DID NOT HAVE THE PACKAGE OF THE PRODUCT. AS OF (B)(6) 2021, THE OPEN SORES WERE HEALING, AND THEY APPEARED TO BE SCABBING OVER. THEY WERE NOT PAINFUL UNLESS THEY WERE TOUCHED. MULTIPLE

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11858043 ↗
• InjuryApr 13, 2021Off-Label Use; Off-Label Use

  ON 24-MAR-2021, A SPONTANEOUS REPORT WAS RECEIVED VIA TELEPHONE FROM A CONSUMER REGARDING A (B)(6)-YEAR OLD FEMALE (ETHNICITY NOT REPORTED) WHO WAS USING THERMACARE NECK/SHOULDER/WRIST 8 HR 3CT (LOT NUMBER: LEF0574; EXPIRATION DATE: JUL-2023). MEDICAL HISTORY INCLUDED 4 PRIOR EYE OPERATIONS, POOR EYESIGHT, ASTHMA WITH USAGE OF A RESCUE INHALER, SCIATICA PAIN, NECK HERNIATIONS, A NECK SURGERY, AND HYPERTENSION. CONCOMITANT PRODUCTS INCLUDED AN UNSPECIFIED ASTHMA RESCUE INHALER AND UNSPECIFIED MEDICATIONS FOR HYPERTENSION. THE REPORTER DECLINED TO PROVIDE FURTHER DETAILS REGARDING MEDICAL HISTORY AND ABOUT CONCOMITANT PRODUCTS. ON (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED THE THERMACARE NECK/SHOULDER/WRIST 8 HR 3CT TO HER LOWER RIGHT BUTTOCK AND UPPER RIGHT THIGH FOR SCIATICA PAIN. SHE APPLIED THE PRODUCT DIRECTLY TO HER SKIN. SHE APPLIED THE PRODUCT DURING THE DAY (ON (B)(6) 2021) FOR 8 HOURS AND THEN SHE WENT TO BED. APPROXIMATELY 8 HOURS AFTER GOING TO BED (SHE WORE THE PRODUCT FOR 16 HOURS TOTAL), SHE WOKE UP WITH AN EXTREME BURNING SENSATION AT THE APPLICATION SITE. WHEN SHE REMOVED THE PRODUCT, SHE FOUND A BURN AT THE APPLICATION SITE THAT LOOKED LIKE RED STREAKS AND CIRCLES

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11660795 ↗
• InjuryJan 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT VERBATIM [PREFERRED TERM] ITCHING BURN SENSATION/BLISTER/ASSUMING IT WAS LIKE A BURN BLISTER/ITCHING STARTED TO TINGLE [BURNS SECOND DEGREE], BLISTER OPENED UP [BLISTER RUPTURE], THOUGHT THE WRAP MAY BE IT WAS DEFECTIVE [DEVICE DEFECTIVE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. THIS 31-YEAR-OLD FEMALE CONSUMER STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) LOT NUMBER DK2625, EXPIRATION DATE FEB2023, UDI NUMBER (B)(4), AT ONE WRAP APPLIED TO THE BACK OF HER LOWER NECK FROM (B)(6) 2021 FOR SORE, NECK PAIN AND FELT STIFF. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NONE. CONSUMER REPORTED FOR 3 COUNT OF THERMACARE NECK, SHOULDER & WRIST WRAPS. SHE WORE ONE AND EVERYTHING WAS GREAT. A FEW DAYS SHE PUT ON ANOTHER ONE FOR THREE HOURS AND IT WAS ITCHING AND LEFT BLISTERS ON HER NECK. SHE WAS ASSUMING IT WAS LIKE A BURN BLISTER, OCCURRED TODAY ((B)(6) 2021), STATED THAT ONLY ONE BLISTER OPENED UP AND SHE THOUGHT SHE SCRATCHED IT WHILE TRYING TO TAKE OFF WRAP. IT WAS TENDER AROUND IT. SHE USED SOAP AND WATER TO CLEAN IT AND PLACED A BAND-AID ON IT. IT WAS AN ITCHING BURN SENSATION, NOT STINGING BURN SENSATION, IT WAS ABOUT

  Patient problems: Blister; Burn, Thermal; Itching Sensation; Skin Burning Sensation

  MAUDE report 11204460 ↗
• MalfunctionDec 23, 2020Insufficient Heating; Tear, Rip or Hole in Device Packaging; Insufficient Heating; Tear, Rip or Hole in Device Packaging

  EVENT VERBATIM [PREFERRED TERM] 1 WRAPPER HAD A HOLE IN IT, AND THE OTHER ONE LOOKED LIKE IT WAS MELTED WHERE THE END WAS CUT ON THE BOTTOM RIGHT SIDE [DEVICE BREAKAGE], , NARRATIVE: THE INITIAL CASE WAS MISSING THE FOLLOWING MINIMUM CRITERIA: [NO ADVERSE EFFECT]. UPON RECEIPT OF FOLLOW-UP INFORMATION ON [14DEC2020], THIS CASE NOW CONTAINS ALL REQUIRED INFORMATION TO BE CONSIDERED VALID. THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A MALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST), DEVICE LOT NUMBER EC2269, EXPIRATION DATE JUN2023, UPC NUMBER: (B)(4),VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTER STATED HE FOUND ON (B)(6)2020 BOTH WRAPS WERE ROCK HARD. HE PUT ONE OF THEM ON HIS NECK, BUT IT DIDN'T HEAT UP, SO HE DIDN'T EVEN TRY THE OTHER ONE. THE 3RD WRAP IN THE BOX WAS SOFT, SO HE USED THAT ONE AND IT WORKED. THE REPORTER STATED THAT THE CORNER OF PACKAGING WAS KIND OF FUNKY. CLARIFIED THAT 1 WRAPPER HAD A HOLE IN IT, AND THE OTHER ONE LOOKED LIKE

  Patient problems: Insufficient Information

  MAUDE report 11065908 ↗
• InjuryNov 3, 2020Unexpected Therapeutic Results; Use of Device Problem; Therapeutic or Diagnostic Output Failure; Excessive Heating; Unexpected Therapeutic Results; Use of Device Problem; Therapeutic or Diagnostic Output Failure; Excessive Heating

  EVENT VERBATIM [PREFERRED TERM]: GOT BURNED BY THE LAST ONE, AND THIS ONE/THEY WERE BURNING SKIN [THERMAL BURN], SHE HAS A RED WELT ON HER SKIN [URTICARIA], IT WAS TOO, TOO HOT/THE MUSCLES WERE SWELLING FROM HAVING MORE HEAT THAT WAS TOO INTENSE [DEVICE ISSUE], HAD A HARD TIME WALKING, LIKE THE MUSCLES WERE SWELLING FROM HAVING MORE HEAT THAT WAS TOO INTENSE [GAIT DISTURBANCE], HAD A HARD TIME WALKING, LIKE THE MUSCLES WERE SWELLING FROM HAVING MORE HEAT THAT WAS TOO INTENSE [MUSCLE SWELLING], IT WASN'T HELPING HER BACK PAIN, IT WAS ACCELERATING PAIN FROM HER LOWER LUMBAR [DEVICE INEFFECTIVE], MAKING MORE PAIN FOR HER BACK/IT WAS ACCELERATING PAIN FROM HER LOWER LUMBAR [BACK PAIN], PUT IT ON HER BACK BY HER LUMBAR FOR BACK PAIN [DEVICE USE ISSUE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A 71-YEAR-OLD FEMALE PATIENT STARTED TO USE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST), DEVICE LOT NUMBER DK2617, EXPIRATION DATE FEB2023, UPC/UDI NUMBER (B)(4), FROM AN UNSPECIFIED DATE AT ONE HEAT WRAP APPLIED TO LOWER BACK/LUMBAR AS NEEDED FOR BACK PAIN. MEDICAL HISTORY INCLUDED ONGOING BLOOD PRESSURE HIGH AND ONGOING KIDNEY DISEASE, AND PATIE

  Patient problems: Ambulation or Postural Difficulties; Burn, Thermal; Swelling; Urticaria

  MAUDE report 10778140 ↗
• InjuryOct 2, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  EVENT VERBATIM [PREFERRED TERM]. SHE USED IT AND IT CAUSED AN ALLERGIC REACTION/ALLERGIC REACTION TO THERMACARE NECK WRAPS [HYPERSENSITIVITY], RASH ON HER SKIN/IT GOT WORSE THROUGHOUT THE DAY, EXPANDING THROUGH THE BODY AND FACE [RASH]. ITCHING [PRURITUS], BROKE OUT IN HIVES ALL OVER HER BODY [URTICARIA], INFLAMMATION CAUSED BY THE ALLERGIC REACTION [INFLAMMATION], NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HERSELF. A 44-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST), DEVICE LOT NUMBER EC2269, EXPIRATION DATE 30JUN2023, UPC NUMBER: 305733015025, TOPICAL FROM (B)(6) 2020 AT ONE WRAP APPLIED TO SKIN ONCE FOR SPASM IN SHOULDER. THERE WERE NO MEDICAL HISTORY AND CONCOMITANT MEDICATIONS. THE PATIENT STATED SHE BOUGHT THERMACARE NECK, SHOULDER, AND WRIST, AND THE BOX DIDN'T HAVE THE INGREDIENTS, OR THE POUCH, AND SHE USED IT ON (B)(6) 2020 AND IT CAUSED AN ALLERGIC REACTION. SHE ONLY HAD IT FOR ONE HOUR, AND REALIZED THERE WAS A RASH ON HER SKIN. IT GOT WORSE THROUGHOUT THE DAY, EXPANDING THROUGH THE BODY AND FACE. SHE WAS STILL TAKING MEDICATION TO DECREASE THE INFLAMMATION CAUSED BY THE ALLERGIC

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Rash

  MAUDE report 10619449 ↗
• MalfunctionAug 14, 2020Material Protrusion/Extrusion; Excessive Heating; Material Protrusion/Extrusion; Excessive Heating

  DID NOTICE THAT IT DID GET AWFUL HOT [DEVICE ISSUE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A (B)(6) FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST), DEVICE LOT NUMBER CW9500, EXPIRATION DATE OCT2022, UDI NUMBER (B)(4), FROM (B)(6) 2020 AT 1 WRAP TO NECK AREA FOR STIFF NECK. MEDICAL HISTORY INCLUDED INJURED HER KNEE ON THE TENNIS COURT. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT SAID WHILE WATCHING TV, SHE WAS LAYING ON A PILLOW AND IT WAS CAUSING HER NECK TO GET STIFF. SHE SAID IT MAY HAVE BEEN 3 PILLOWS. SHE USED THESE THERMACARE HEATWRAPS FOR NECK AND THEY DID NOT WANT TO STAY ON. SHE TRIED ONE AND IT KEPT FALLING OFF. SHE PRESSED DOWN ON IT LIKE IT SAID, AND HELD IT FOR 30 SECONDS TO A MINUTE. THE ADHESIVE WOULD NOT ADHERE TO HER SKIN. SHE TRIED TWO OF THEM. SHE ALSO HAD A PROBLEM IN THE PAST. IT WAS A LONG TIME AGO. SHE HAD INJURED HER KNEE ON THE TENNIS COURT. THAT ONE DID NOT STAY ON EITHER, ESPECIALLY LIKE WHEN WALKING WITH IT. IT DID NOT WANT TO STAY ON, NO MATTER HOW TIGHT SHE PUT IT. IT WAS JUST LIKE THE NECK WRAP. SHE TRIED TO PRESS IT DOWN. SHE ALMOST THOUGHT ABO

  Patient problems: Neck Stiffness

  MAUDE report 10407816 ↗
• MalfunctionApr 1, 2020Improper or Incorrect Procedure or Method; Component Missing

  SKIN RASH [RASH], ADHESIVE MISSING ON ONE SIDE OF THE WRAPS, DUE TO THIS SHE WAS PUTTING ADHESIVE TAPE AND THAT ADHESIVE TAPE GAVE HER A RASH [DEVICE ADHESION ISSUE], SHE WAS PUTTING ADHESIVE TAPE AND THAT ADHESIVE TAPE GAVE HER A RASH [DEVICE USE ERROR]. CASE NARRATIVE: THE INITIAL CASE WAS MISSING THE FOLLOWING MINIMUM CRITERIA: THERE IS NO INDICATION THAT THE PATIENT EXPERIENCED AN EVENT UNDER THERMACARE NECK, SHOULDER & WRIST (PRODUCT COMPLAINT ONLY). UPON RECEIPT OF FOLLOW-UP INFORMATION ON 04-MAR-2020, THIS CASE NOW CONTAINS ALL REQUIRED INFORMATION TO BE CONSIDERED VALID. THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) UDI NUMBER (B)(4), FROM AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. DEVICE LOT NUMBER AND EXPIRATION DATE WERE NOT AVAILABLE. MEDICAL HISTORY INCLUDED BAD CAR ACCIDENT, HIT BY DRUNK DRIVER MANY YEARS AGO. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT LOVED THERMACARE HEATWRAP, THESE WERE LIFE SAVER FOR HER. SHE HAS USED THEM FOR MANY YEARS. IT WAS A 3-COUNT BOX AND THERE WAS ADHESIVE MISSING ON ONE

  Patient problems: Rash

  MAUDE report 9913893 ↗
• InjuryDec 3, 2019Use of Device Problem

  BURNS [THERMAL BURN], HAD ONE ON MY STOMACH AND I HAD ONE ON MY BACK [DEVICE USE ERROR]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). THIS (B)(6)-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) LOT NUMBER AK5122, EXPIRATION DATE: DEC2021, FROM AN UNSPECIFIED DATE FOR BACK PROBLEMS. RELEVANT MEDICAL HISTORY INCLUDED BACK PROBLEMS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECENTLY (AS OF (B)(6) 2019) BOUGHT A WHOLE BUNCH OF THERMACARE WRAPS IN THE LOCAL PHARMACY AS THEY WERE ON SALE. SHE HAD BEEN BUYING THEM FOR YEARS FOR AS LONG AS THEY HAVE BEEN AROUND. SHE HAD BACK PROBLEMS AND ALWAYS BOUGHT THE NECK ONE, THE NECK, WRIST AND SHOULDER HEATWRAPS AND THE ACTUAL BACK ONES IN THE LARGE EXTRA-LARGE SIZE. WHEN HOME SHE ALWAYS TAKES THEM ALL OUT OF THE BOX, USUALLY AS SOON AS SHE GETS HOME, AND STORES THEM INTO A BAG LIKE A TOTE BAG TO JUST GRAB THEM, AND THEN JUST PULL THEM OUT AS SHE NEEDS THEM. THIS TIME THE PATIENT PULLED OUT ONLY A COUPLE OF THEM. THE PATIENT USED ONE OF THE BACK ONES AND ONE OF THE NECK ONES AND GOT BURNS ON BOTH OF THEM. SHE WOUND UP GETTING BURNS FROM BOTH OF THE

  Patient problems: Burn, Thermal

  MAUDE report 9401407 ↗
• InjuryOct 31, 2019Use of Device Problem

  BURN DESCRIBED AS ITCHING, LITTLE WELTS DESCRIBED LATER AS RED, RAISED WELTS AS BURN [THERMAL BURN] , SHE BOUGHT AND USED THE WRAPS TO EASE LABOR PAINS [DEVICE USE ISSUE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). THIS CONSUMER REPORTED TWO DEVICES. THIS IS THE FIRST OF 2 REPORTS. A 43-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST), UPC NUMBER: 305733015025, DEVICE LOT NUMBER W24816, EXPIRATION DATE DEC2020, IN (B)(6) 2018 AT AN UNKNOWN FREQUENCY FOR "HAVING EARLY LABOR SYMPTOMS AT HOME" AND TO EASE LABOR PAINS. THE PATIENT MEDICAL HISTORY INCLUDED SKIN WAS SENSITIVE. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT PREVIOUSLY USED THERMACARE HEATWRAPS AND NOTED THAT BURN HAD HAPPENED PREVIOUSLY AND PATIENT GAVE AN AGE OF 33-YEAR-OLD WHEN THE EVENT FIRST OCCURRED. THE PATIENT EXPERIENCED BURN IN (B)(6) 2018. THE BURN WAS DESCRIBED AS THAT SHE COULD TELL IT WAS THERE, THERE WAS ITCHING AND WHEN SHE LOOKED, SHE COULD SEE THE OUTLINE OF THE LITTLE CIRCLES FROM THE PRODUCT, "LITTLE WELTS" WHICH WAS DESCRIBED LATER AS RED, RAISED WELTS AS BURN. SHE PUT A COLD WASHCLOTH ON UN

  Patient problems: Burn, Thermal; Itching Sensation; Pain; Swelling

  MAUDE report 9260668 ↗
• MalfunctionSep 6, 2019Unsealed Device Packaging; Manufacturing, Packaging or Shipping Problem

  IT HAD A DEFECT IN THE CENTER, TOP OF THE PAD WHICH CAUSED IT TO RUB HIS SKIN AND CREATED A SLIGHT BIT OF PAIN. [PAIN], IT HAD A DEFECT IN THE CENTER, TOP OF THE PAD WHICH CAUSED IT TO RUB HIS SKIN AND CREATED A SLIGHT BIT OF PAIN/SOMETHING SHARP DUG INTO SKIN [SKIN DISCOMFORT], IT WAS JUST A QUICK LITTLE SCRATCH, IT DIDN'T BREAK THE SKIN [SCRATCH], IT HAD A DEFECT IN THE CENTER, TOP OF THE PAD/THE DEFECT WAS RIDGED AND SOMEWHAT SHARP [DEVICE ISSUE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HIMSELF. A (B)(6)-YEAR-OLD MALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST), DEVICE LOT NUMBER W69234, EXPIRATION DATE JAN2021, UPC NUMBER: (B)(4) (ALSO REPORTED AS UDI NUMBER), FROM (B)(6) 2019 AT ONE WRAP APPLIED TO SKIN ONCE FOR SLIGHT MUSCLE PAIN/ SLIGHT PAIN, ALSO REPORTED 1 PER DAY FOR ABOUT A WEEK FOR NECK PAIN FROM AN UNKNOWN DATE "AS PAIN COMES AND GOES". THERE WAS NO RELEVANT MEDICAL HISTORY. CONCOMITANT MEDICATION INCLUDED ONGOING NAPROXEN FROM (B)(6) 2019, AS NEEDED/PERIODICALLY THROUGHOUT THE YEARS. THE PATIENT HAD BEEN USING THERMACARE PRODUCTS FOR 10 TO 12 YEARS FOR VARIOUS REASONS, MOSTLY LOWER B

  Patient problems: Pain; Skin Tears

  MAUDE report 8969376 ↗
• MalfunctionJun 17, 2019Insufficient Heating; Leak/Splash; Use of Device Problem; Break; Insufficient Heating; Leak/Splash; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  EVENT VERBATIM [PREFERRED TERM] SHE USED THE NECK WRAPS FOR HER BACK [DEVICE USE ISSUE] , LOOKED INSIDE THE GRANULES OR WHATEVER IT'S CALLED THAT ARE IN THE HEATWRAPS WERE ALL OVER THE BOX [DEVICE LEAKAGE], CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTED FOR HERSELF. A 61-YEARS-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST), DEVICE LOT NUMBER X25940, EXPIRATION DATE AUG2021, UDI NUMBER (B)(4), FROM AN UNSPECIFIED DATE AND ONGOING AT PEEL OFF THE PAPER AND STUCK IT ON HER BACK FOR BACK PAIN AND PAIN. MEDICAL HISTORY WAS NONE. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT SAID SHE JUST USED HER THERMACARE HEATWRAPS, ADVANCE NECK PAIN THERAPY, AND IT'S NOT EXPIRED AND SHE HAD THE BOX. WHEN SHE OPENED THE BOX AND LOOKED INSIDE THE GRANULES OR WHATEVER IT'S CALLED THAT ARE IN THE HEATWRAPS WERE ALL OVER THE BOX. SHE PUT ON ONE AND IT DIDN'T WORK, IT DIDN'T HEAT UP ON (B)(6) 2019. ON (B)(6) 2019, SHE WAS USING THE PRODUCTS FOR HER BACK, WHICH WAS KILLING HER. SHE HAD ONE OTHER ONE HEATWRAP THAT WAS NOT OPENED. SHE HAD NEVER HAD THIS PROBLEM BEFORE AND SHE HAD USED THEM ALL THE TIME. SHE LATER CLARIFIED T

  Patient problems: Chemical Exposure

  MAUDE report 8704082 ↗