ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & Hip (UDI 00305733010037)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00305733010037), received between Feb 15, 2019 and Sep 16, 2022 — classified as 30 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (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 37 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A 65-YEAR-OLD MALE WHO USED A THERMACARE LOWER BACK AND HIP 8 HR L/XL HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON APPROXIMATELY (B)(6) 2022, THE CONSUMER APPLIED THE THERMACARE LOWER BACK AND HIP 8 HR L/XL HEAT WRAP TO HIS STOMACH AND THEN WENT TO BED AND FELL ASLEEP WHILE WEARING THE HEAT WRAP. APPROXIMATELY 8 TO 10 HOURS AFTER SLEEPING WHILE WEARING THE HEAT WRAP, HE WOKE UP ON HIS SIDE AND THE SKIN AT THE APPLICATION SITE WAS RED. THE SIDE OF HIS STOMACH THAT HE SLEPT ON WAS COVERED WITH BLISTERS. THE CONSUMER'S FRIEND ADVISED THE CONSUMER NOT TO WEAR THE PRODUCT DIRECTLY WHILE SLEEPING, BUT HE DID ANYWAY. IT WAS A BURN. THE BLISTERS WERE NOT OPEN, AND THEY WERE NOT GETTING WORSE. FOR TREATMENT, THE CONSUMER HAD BEEN APPLYING AN ANTIBIOTIC OINTMENT TO THE AREA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15439866 ↗
• InjurySep 2, 2022Excessive Heating; Excessive Heating

  ON 17-AUG-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A 49-YEAR-OLD FEMALE WHO USED A THERMACARE LOWER BACK AND HIP L/XL HEAT WRAP. MEDICAL HISTORY INCLUDED BACKPAIN AND DIABETES TYPE II. CONCOMITANT PRODUCTS INCLUDED METFORMIN AND GLIPIZIDE. ON (B)(6) 2022, THE CONSUMER APPLIED A THERMACARE LOWER BACK AND HIP L/XL HEAT WRAP FOR BACK PAIN OVER A TANK TOP. AFTER WEARING THE HEAT WRAP FOR 6 TO 7 HOURS, THE CONSUMER EXPERIENCED A BURNING SENSATION AND IRRITATION. SHE TOOK OFF THE WRAP. THE CONSUMER'S RELATIVE LOOKED AT THE DEVICE SITE AND NOTED THERE WERE RED WELTS AND BLISTERS ON HER BACK WHICH WERE THE SIZE OF SILVER DOLLARS. SHE HAD SEVERE PAIN AND CHILLS. SHE HAD A SEVERE BURN. ON (B)(6) 2022, THE CONSUMER SPOKE WITH HER PRIMARY MEDICAL DOCTOR AND PROVIDED PICTURES. SHE WAS PRESCRIBED ORAL KEFLEX (CEPHALEXIN) AND SILVADENE (SILVER SULFADIAZINE). ON (B)(6) 2022, IT WAS THE FIRST DAY SHE FELT UP TO GETTING AROUND BECAUSE OF THE PAIN. HER SYMPTOMS WERE STILL PRESENT, AND SHE THOUGHT SHE MIGHT BE CALLING HER DOCTOR. AS OF (B)(6) 2022, THE CONSUMER WAS STILL APPLYING SILVADENE AND TAKING KEFLEX. THE AREA WAS SLOWING HEALING. NO ADDITIONAL INFORMAT

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

  MAUDE report 15348262 ↗
• InjurySep 2, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 12-AUG-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A 30-YEAR-OLD FEMALE WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY INCLUDED AN UNSPECIFIED THYROID DISORDER AND PRIOR USE OF THERMACARE FOR YEARS WITHOUT EVENT. CONCOMITANT PRODUCTS INCLUDED SYNTHROID (LEVOTHYROXINE). ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP TO HER LOWER ABDOMEN BECAUSE SHE SHOULD NOT FIND THE MENSTRUAL CRAMP PRODUCT. SIX HOURS AFTER WEARING THE PRODUCT, SHE REMOVED IT AND NOTICED THAT THE SITE WAS RED AND IRRITATED. THE NEXT MORNING, SHE NOTICED TWO PAINFUL BLISTERS. SHE COULD LINE UP THE BLISTER AREAS WITH THE DEVICE. ONE BLISTER WAS JUST RIGHT FROM THE CENTER THAT WAS THE SIZE OF A HALF DOLLAR. THE OTHER BLISTER WAS JUST LEFT OF THE CENTER AND THE SIZE OF A NICKEL. TWO DAYS LATER THE BLISTERS RUPTURED. HER FATHER, WHO WAS A PHYSICIAN, LOOKED AT THE AREA. SHE STATED SHE HAD A PRETTY BAD SECOND DEGREE BURN FROM THE WRAP. ON (B)(6) 2022, SHE STARTED TREATMENT WITH PRESCRIPTION SILVADENE (SILVER SULFADIAZINE) APPLIED TO THE AREA TWICE A DAY. SHE WAS INSTRUCTED TO WEAR LOOSE FITTED CLO

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

  MAUDE report 15348250 ↗
• InjuryJul 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED REGARDING A 62-YEAR-OLD MALE WHO USED THERMACARE LOWER BACK & HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY INCLUDED HIGH CHOLESTEROL, ANXIETY, HIP PAIN, AN ARTIFICIAL HIP, DIABETES, HUMAN IMMUNODEFICIENCY VIRUS, AND AN ALLERGY TO CALAMINE LOTION. THE CONSUMER USED UNSPECIFIED MEDICATIONS (DECLINED TO PROVIDE). ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK & HIP 8HR L/XL HEAT WRAP DIRECTLY TO THE SKIN OF HIS LOWER BACK AND WENT TO BED AT 10 AM. AT 5 PM THE SAME DAY, AFTER WAKING UP AND AFTER 8 HOURS OF USE, HE REMOVED THE WRAP. HE HAD AN ACID MARK ON HIS BACK. IT WAS CLARIFIED THAT THE HEAT WRAP LEFT A RED, RAW MARK RIGHT WHERE HE PUT THE WRAP. IT BURNED HIM "REALLY BAD". FOR TREATMENT, HE CLEANED THE AREA AND ANTICIPATED FOLLOWING UP WITH HIS MEDICAL DOCTOR FOR TREATMENT. THE CONSUMER NOTED HE REALIZED THAT HE PUT THE WRAP DIRECTLY ON HIS SKIN EVEN THOUGH THE LABEL INDICATES TO USE A CLOTHING BARRIER IF ABOVE THE AGE OF 55. IT WAS THE FIRST TIME HE USED THE HEAT WRAP.

  Patient problems: Burn(s); Erythema; Skin Discoloration; Skin Erosion

  MAUDE report 15095128 ↗
• InjuryJul 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A 77-YEAR-OLD MALE WHO USED A THERMACARE LOWER BACK AND HIP L/XL 8HR HEAT WRAP. MEDICAL HISTORY INCLUDE PAIN. FURTHER MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP L/XL 8HR HEAT WRAP TO HIS LOWER BACK. ON (B)(6) 2022, AFTER USING THE PRODUCT, THE CONSUMER TOOK A SHOWER AND FELT A BURNING SENSATION FROM A DIME SIZE AREA ON HIS LOWER BACK. THE AREA LOOKED LIKE A BURN. THE HEAT WRAP WAS INTACT AND WITHOUT ANY TEARS. ON (B)(6) 2022, THE CONSUMER CALLED A DOCTOR AND A NURSE ADVISED HIM TO APPLY ALOE VERA CREAM TO THE AFFECTED AREA. AS OF (B)(6) 2022, THE CONSUMER ANTICIPATED MAKING AN APPOINTMENT WITH HER PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s); Burning Sensation; Ulcer

  MAUDE report 15004792 ↗
• InjuryJun 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 10-JUN-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A 59-YEAR-OLD FEMALE WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. ALLERGIES INCLUDED ALLERGIES TO WASPS AND ALEVE (NAPROXEN). MEDICAL HISTORY INCLUDED PRIOR USE OF THERMACARE WITHOUT ISSUE. CONCOMITANT PRODUCTS INCLUDED A MULTIVITAMIN. ON APPROXIMATELY (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP TO THE LUMBAR REGION OF HER BACK PRIOR TO WORK. AFTER WORK AND WHEN SHE REMOVED THE WRAP, SHE FOUND SHE HAD DEVELOPED BLISTERS AT HER WAISTBAND. SHE WAS A NURSE AND TREATED THE ABRASIONS WITH ANTIBIOTIC CREAM AND COVERED THEM WITH A BAND-AID. A WEEK LATER, THE BLISTERS ERUPTED, AND SHE HAD "HOLES" IN HER BACK WHERE THE BLISTERS USED TO BE. SHE WAS NOT ABLE TO SLEEP ON HER BACK DUE TO THE DISCOMFORT OF THE AREA. SHE DENIED WEARING THE PRODUCT FOR MORE THAN 8 HOURS AND NOTED THAT SHE DID NOT NEED TO WEAR CLOTHING BETWEEN HER SKIN AND THE WRAP EVEN THOUGH IT WAS RECOMMENDED FOR CONSUMER ABOVE 55 YEARS OF AGE. ON (B)(6) 2022, HER HEALTH CARE PRACTITIONER LOOKED AT HER BACK AND WAS TOLD IT LOOKED LIKE A BURN. FOR TREATMENT, SHE WAS GIVEN A

  Patient problems: Abrasion; Blister; Burn(s); Ulcer

  MAUDE report 14843000 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON 04-SEP-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A FEMALE CONSUMER WHO USED THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE THE CONSUMER OPENED UP A BOX OF THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS AND NOTICED THERE WAS BLACK ON THE INSIDE OF IT. THE CONSUMER NOTED IT LOOKED LIKE ONE OF THE LITTLE PADS HAD BEEN LEAKING STUFF ON THE HEAT WRAP. SHE THOUGHT THAT DURING THE PACKAGING AND STITCHING WENT THROUGH THE WRAP CAUSING LEAKAGE OF BLACK SUBSTANCES ON THE WRAP IN TWO AREAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118360 ↗
• InjuryApr 13, 2022Off-Label Use; Off-Label Use

  ON 22-MAR-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A (B)(6) AFRICAN AMERICAN FEMALE WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY INCLUDED HIGH BLOOD PRESSURE AND TYPE II DIABETES. THE CONSUMER WAS ALLERGIC TO SEAFOOD AND WAS A NON-SMOKER. CONCOMITANT PRODUCTS INCLUDED METFORMIN AND HYDROCHLOROTHIAZIDE. AT 6:00 ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP TO HER LOWER BACK FOR AN UNSPECIFIED INDICATION. AT 16:00 ON (B)(6)2022, THE CONSUMER TOOK THE HEAT WRAP OFF. SHE EXPERIENCED A BURNING SENSATION AND A BLISTER. FOR TREATMENT SHE WASHED THE AREA WITH WARM WATER WITH SOAP AND APPLIED NEOSPORIN. SHE WORKED AT A HEALTHCARE FACILITY AND THE NURSES WHERE SHE WORKED ADVISED HER TO USE OVER-THE-COUNTER (OTC) BURN CREAM. SUBSEQUENTLY, SHE HAD BEEN APPLYING NEOSPORIN AND AN OTC BURN CREAM. AS OF (B)(6 )2022, THE AREA WAS MUCH BETTER, AND SHE NO LONGER HAD THE BLISTER OR BURNING PAIN. THE AREA WHERE THE DEVICE WAS PLACED WAS STILL PINKISH AND IT WAS RESOLVING. SHE DID NOT SEEK MEDICAL ATTENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blister; Burning Sensation; Erythema

  MAUDE report 14106266 ↗
• MalfunctionApr 5, 2022Excessive Heating; Excessive Heating

  ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A MALE CONSUMER (AGE NOT PROVIDED) WHO WAS USING THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS FROM A 2-PACK BOX. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS APPLIED TOPICALLY FOR AN UNSPECIFIED INDICATION. ON AN UNSPECIFIED DATE, AFTER USING THE HEAT WRAP, ONE OF THE WRAPS WAS TOO HOT AND THE OTHER DID NOT HAVE ENOUGH HEAT. THE CONSUMER HAD NO FURTHER COMPLAINTS AND DECLINED TO PROVIDE FURTHER INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014338 ↗
• MalfunctionMar 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON 10-FEB-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6) FEMALE CONSUMER WHO USED THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY INCLUDED ASTHMA, DIABETES, "NEARLY BLIND", AND MYELODYSPLASTIC SYNDROME. THE REPORTER DECLINED TO PROVIDE CONCOMITANT PRODUCTS. ON AN UNSPECIFIED DATE, APPROXIMATELY SINCE 2017, THE CONSUMER HAS APPLIED APPROXIMATELY 4 THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS (LOT NUMBERS NOT PROVIDED; ONE EXPIRATION DATE WAS KNOWN 15-JAN-2022) PER WEEK WITHOUT ISSUES. ON UNSPECIFIED DATES, REPORTED AS "RECENT", THE CONSUMER EXPERIENCED ONE HEAT WRAP DID NOT HEAT UP. SHE ALSO EXPERIENCED ONE OF THE HEAT WRAPS BROKE. IT WAS FURTHER CLARIFIED THAT IT LEAKED. THE CONSUMER DISCARDED THE PRODUCTS AND WAS UNABLE TO PROVIDE ANY FURTHER SPECIFIC DEVICE INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716182 ↗
• InjuryFeb 9, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 13-JAN-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING AN (B)(6) MALE CONSUMER WHO WAS USING THERMACARE HEATWRAPS BACK PAIN THERAPY L-XL 2CT. MEDICAL HISTORY INCLUDED A CONSTANT COUGH, HYPERTENSION, HIGH CHOLESTEROL, AND THE CONSUMER WAS A NON-SMOKER. THE CONSUMER HAD NO KNOWN ALLERGIES. CONCOMITANT PRODUCTS INCLUDED SIMVASTATIN FOR HIGH CHOLESTEROL, AN UNSPECIFIED HYPERTENSION MEDICATION, AND VITAMIN D. ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE HEATWRAPS BACK PAIN THERAPY L-XL 2CT (LOT NUMBER: GA0104; EXPIRATION DATE: 31-JUL-2024) TO HIS LOWER BACK OVER HIS UNDERWEAR FOR AN UNSPECIFIED INDICATION. AFTER 6 HOURS OF APPLICATION, THE CONSUMER FOUND HIS SKIN HAD A RED MARK WHERE HIS UNDERWEAR WAS NOT COVERING HIS SKIN. HE NOTED IT WAS A BURN ACROSS HIS LOWER BACK WAISTLINE. IT WAS 12 INCHES ACROSS AND RED. THE CONSUMER DID NOT EXPRESS ANY PAIN OR DISCOMFORT, BUT THE REPORTER NOTED THAT HE TYPICALLY WOULDN'T COMPLAIN EVEN IF ANY WAS PRESENT. THE REPORTER THOUGHT THAT THE HIS UNDERWEAR MAY HAVE SHIFTED WHILE HE WAS WEARING THE HEAT WRAP WHICH CAUSED DIRECT CONTACT WITH HIS SKIN. THE CONSUMER DID NOT PERFORM AND

  Patient problems: Erythema; Superficial (First Degree) Burn

  MAUDE report 13498222 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 08-DEC-2021, A SPONTANEOUS REPORT WAS RECEIVED FROM THE UNITED STATES VIA TELEPHONE REGARDING A FEMALE (AGE NOT REPORTED) WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE THE CONSUMER USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP (EXPIRATION DATE: 31-JAN-2024; LOT NUMBER: GA0052). ON AN UNSPECIFIED DATE, AFTER USING A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP, THE CONSUMER EXPERIENCED BURNS. IT WAS FURTHER STATED THAT SHE HAD SECOND DEGREE BURNS IN ALL AREAS OF THE BODY WHERE SHE WAS USING IT. THE CONSUMER NOTED THAT SHE USED IT AS DIRECTED. FOLLOW-UP ATTEMPTS HAVE BEEN UNSUCCESSFUL IN ESTABLISHING CONTACT WITH THE CONSUMER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 13180410 ↗
• MalfunctionDec 28, 2021Excessive Heating; Excessive Heating

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A CONSUMER REGARDING A (B)(6) FEMALE WHO USED A THERMACARE LOWER BACK AND HIP 8HOUR L/XL HEAT WRAP. MEDICAL HISTORY INCLUDED ASTHMA. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HOUR L/XL HEAT WRAP (LOT NUMBER: GA0105; EXPIRATION DATE 31-AUG-2021) TO HER LOWER BACK. IT WAS THE FIRST TIME SHE USED THE HEAT WRAP AND SHE APPLIED IT OVER HER SHIRT. AFTER ONE HOUR THE HEAT WRAP BECAME WARM AND PROVIDED PAIN RELIEF. AFTER APPROXIMATELY 2 HOURS OF APPLICATION, THE THERMACARE LOWER BACK AND HIP BEGAN TO FEEL EXTREMELY HOT, AND IT CAUSED A PAINFUL BURNING SENSATION. SHE HAD THE DEVICE ON FOR APPROXIMATELY 4 OR 5 HOURS. SHE WENT TO THE RESTROOM AT WORK AND REMOVED THE WRAP AND TOOK A PICTURE OF THE APPLICATION SITE. THE AREA HAD BECOME RED, AND SHE HAD 2 AREAS WHERE THE SKIN PEELED OFF, LIKE A SUNBURN. NO OOZING, PUSS, OR SORES WAS PRESENT. SHE STATED THAT SHE HAD SOME REDNESS AND BURNS ON HER BACK. FOR TREATMENT SHE APPLIED NEOSPORIN AND USED GAUZE TO PROTECT IT. SHE HAD NOT USED THE DEVICE AGAIN. AS OF (B)(6) 2021, ONE SIDE O

  Patient problems: Burn(s); Pain; Peeling; Skin Discoloration

  MAUDE report 13094009 ↗
• InjuryDec 10, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING AN (B)(6) FEMALE CONSUMER WHO WAS USING THERMACARE LOWER BACK & HIP 8HR L/XL. MEDICAL HISTORY WAS NOT REPORTED. THE CONSUMER WAS A NON-SMOKER. CONCOMITANT PRODUCTS INCLUDED UNSPECIFIED VITAMINS AND UNSPECIFIED SUPPLEMENTS. ON (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK & HIP 8HR L/XL HEAT WRAP ON HER BACK FOR 6 HOURS FOR AN UNSPECIFIED INDICATION. AFTER 6 HOURS SHE HAD REDNESS, PAIN, AND IT LOOKED LIKE A BURN ON HER BACK ABOVE THE WAIST. ON (B)(6) 2021, SHE WENT TO HER PRIMARY DOCTOR AND WAS TOLD IT WAS SOME KIND OF BURN. FOR TREATMENT SHE WAS GIVEN A PRESCRIPTION FOR 1% SILVER SULFADIAZINE CREAM. SHE HAD NOT USED THE PRODUCT AGAIN. THE CONSUMER NOTED THAT THE PICTURE ON FRONT OF THE BOX SHOWED THE HEAT WRAP BEING APPLIED TO SKIN AND THE BACK OF THE BOX READS TO APPLY THE HEAT WRAP OVER CLOTHING. SHE THOUGHT IT WAS FALSE ADVERTISING. AS OF 17-NOV-2021, FOLLOW UP ATTEMPTS HAVE BEEN UNSUCCESSFUL IN ESTABLISHING CONTACT WITH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: Pain; Superficial (First Degree) Burn

  MAUDE report 12975959 ↗
• InjuryDec 6, 2021Excessive Heating; Excessive Heating

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A FEMALE (AGE NOT REPORTED) WHO USED THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS. MEDICAL HISTORY INCLUDED BACKPAIN. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP (LOT NUMBER NOT PROVIDED; EXPIRATION DATE (B)(6) 2023) APPLIED TOPICALLY TO THE BACK FOR BACK PAIN. AFTER THE CONSUMER HAD THE HEAT WRAP ON FOR 2 HOURS IT "BURN'T THE HELL OUT" OF THE CONSUMER'S BACK. FOLLOW-UP ATTEMPTS HAVE BEEN UNSUCCESSFUL. AS OF (B)(6) 2021, NO NEW ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 12934628 ↗
• InjuryNov 15, 2021Excessive Heating; Excessive Heating

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A FEMALE (REPORTER DECLINED TO PROVIDE THE CONSUMER'S AGE; SHE WAS A SENIOR) WHO WAS USING THERMACARE LOWER BACK AND HIP 8HR L/XL. MEDICAL HISTORY INCLUDED PRIOR USE OF THERMACARE FOR YEARS AND "SEVERAL PAIN CONDITIONS." THE REPORTER REFUSED TO PROVIDE ADDITIONAL MEDICAL HISTORY OR INFORMATION REGARDING CONCOMITANT PRODUCTS. THREE WEEKS PRIOR TO (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED ONE THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP (LOT NUMBER: EK9242, EXPIRATION DATE: 31-OCT-2023) TO HER LOWER BACK DIRECTLY ON THE SKIN. WITHIN A FEW MINUTES, IT BECAME TOO HOT. SUBSEQUENTLY, SHE DOUBLED OVER A HAND TOWEL AND PUT IT BETWEEN THE WRAP AND HER SKIN. AFTER IT WAS ON FOR 15 MINUTES, IT AGAIN BECAME SO HOT THAT SHE WAS VERY UNCOMFORTABLE, AND SHE WANTED TO REMOVE IT. SHE ASKED A STRANGER TO REMOVE IT FOR HER IN A RESTROOM AND SHE PUT IT HER PURSE. HER DISCOMFORT RESOLVED SOON AS THE HEAT WRAP WAS OFF. THERE WAS NO FURTHER DISCOMFORT NOR INJURY. SHE WAS ASYMPTOMATIC. THE HEAT WRAP BECAME VERY HOT INSIDE HER PURSE. THE CONSUMER NOTED THAT THE HEAT WRAP MUST BE DEFECTIVE

  Patient problems: Discomfort

  MAUDE report 12811634 ↗
• InjurySep 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A CONSUMER REGARDING A FEMALE (AGE AND ETHNICITY WERE NOT SPECIFIED) WHO WAS USING A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY INCLUDED PRIOR USE OF THERMACARE "OFF AND ON" WITHOUT ISSUE. THE CONSUMER HAD ALLERGIES TO SULFONAMIDES, CHLORTHALIDONE, AND UNSPECIFIED EYE DROPS. ON AN UNSPECIFIED DATE IN (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED THE THERMACARE LOWER BACK AND HIP 8HR L/XL (LOT NUMBER: EK9242, EXPIRATION DATE: 31-OCT-2023) HEAT WRAP TO HER RIGHT HIP FOR AN UNSPECIFIED INDICATION. AFTER THE CONSUMER APPLIED THE HEAT WRAP, SHE LEFT THE THERMACARE LOWER BACK AND HIP ON FOR "MOST OF THE DAY". WHEN SHE REMOVED THE HEAT WRAP, SHE DID NOT NOTICE ANYTHING. ONE OR TWO DAYS LATER, SHE DEVELOPED BLISTERS AT THE APPLICATION SITE. SHE ACCIDENTLY BROKE ONE OF THE BLISTERS WHILE CHANGING CLOTHES AND IT BECAME "REALLY PAINFUL". THE SKIN WAS OPEN, AND SHE WAS CONCERNED ABOUT THE POSSIBILITY OF INFECTION. SUBSEQUENTLY, THE CONSUMER VISITED AN URGENT CARE. THE DOCTOR DID A VISUAL ANALYSIS AND TOLD HER SHE HAD SECOND DEGREE BURNS AT THE APPLICATION SITE. SHE WAS PRESCRIBED A

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

  MAUDE report 12520116 ↗
• InjuryJul 15, 2021Off-Label Use; Off-Label Use

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING AN (B)(6) MALE WHO USED THERMACARE LOWER BACK AND HIP 8 HR L/XL 2CT. MEDICAL HISTORY INCLUDED DIVERTICULITIS AND THE PATIENT WAS A NON-SMOKER. THE CONSUMER DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING MEDICAL HISTORY AND OF ANY USAGE OF CONCOMITANT PRODUCTS. APPROXIMATELY 3 TO 4 DAYS AGO, RELATIVE TO (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8 HR HEAT WRAP (LOT NUMBER AND EXPIRATION DATE NOT PROVIDED) TO HIS LOWER BACK AND HIPS. HE LEFT THE PRODUCT ON LONGER THAN 8 HOURS. HE DID NOT REALIZE IT HAD LIMITATIONS. HE COULD NOT SAY HOW LONG HE LEFT IT ON EXACTLY, BUT IT WAS SEVERAL HOURS LONGER THAN IT SHOULD HAVE BEEN. APPROXIMATELY 2 DAYS AGO, RELATIVE TO (B)(6) 2021, THE CONSUMER NOTICED STINGING WHERE THE PATCH WAS AND HE ALSO HAD BLISTERS. THE BLISTERS HAD POPPED. FOR TREATMENT, THE CONSUMER HAD BEEN APPLYING FOILLE BURN MEDICATION AND NEOSPORIN TO THE AREA. ON (B)(6) 2021, THE CONSUMER VISITED HIS HEALTHCARE PROVIDER (HCP). THE HCP TOLD HIM HE HAD A SLIGHT BURN FROM THE PRODUCT, BUT IT WAS NOT VERY BAD AND THAT THE HCP HAD SEEN MUCH WORSE. IT

  Patient problems: Blister; Pain

  MAUDE report 12173332 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 20212, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING AN (B)(6) FEMALE WHO WAS USING THERMACARE LOWER BACK AND HIP 8 HR L/X 2CT. MEDICAL HISTORY INCLUDED BACK PAIN AND A HOSPITALIZATION SEVERAL WEEKS AGO (RELATIVE TO (B)(6) 2021) WHICH SHE HAD SEPSIS (BEFORE USING THE DEVICE). CONCOMITANT PRODUCTS INCLUDED AN UNSPECIFIED MULTIVITAMIN. ON APPROXIMATELY (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED ONE THERMACARE LOWER BACK AND HIP 8 HR L/X (LOT NUMBER AD3848; EXPIRATION DATE (B)(6) 2021) TO HER LOWER BACK OVER A TANK TOP FOR BACK PAIN. APPROXIMATELY 5 HOURS AFTER SHE APPLIED THE PRODUCT, SHE EXPERIENCED APPLICATION SITE BURNING AND HAD TO REMOVE THE PRODUCT. WHEN SHE REMOVED THE PRODUCT, SHE NOTICED THAT THERE WERE 3 BLISTERS ON THE APPLICATION SITE. SHE WAS BURNED. SHE COULD SEE THE IMPRINT OF THE PRODUCT ON HER BACK. THE CONSUMER HAS A NURSE WHICH HAD BEEN LOOKING AT THE SITE WITH EACH VISIT. IT WAS CLARIFIED THAT THE HOME NURSE THAT COMES TO VISIT HER WAS PRESENT TO OVERSEE HER PRIOR HOSPITAL DISCHARGE AND RECOVERY FROM HER HISTORICAL SEPSIS. THE NURSE WAS NOTIFIED OF THE CONSUMER'S REACTION. THEY TRIED TO LET IT HEAL BUT IT DID NOT. TH

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11916429 ↗
• InjuryMay 24, 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 FROM A CONSUMER REGARDING A FEMALE CONSUMER WHO USED THERMACARE LOWER BACK AND HIP L/XL 8HR 2CT. MEDICAL HISTORY INCLUDED BACK PAIN. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON THE NIGHT OF (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED THE THERMACARE LOWER BACK AND HIP L/XL 8HR 2CT. ON AN UNSPECIFIED AMOUNT OF TIME AFTER APPLYING THE PRODUCT, THE CONSUMER REMOVED THE WRAP. SHE NOTED HER SKIN WAS BURNED AND SHE HAD BLISTERS. THE CONSUMER MENTIONED SHE CONTACTED HER LAWYER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11872780 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29-APR-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6) YEAR OLD FEMALE CONSUMER WHO USING THERMACARE LOWER BACK AND HIP 8HR L/XL 2 CT HEAT WRAP. MEDICAL HISTORY INCLUDED A HYSTERECTOMY WHICH "MESSED HER HORMONES UP", SEASONAL ALLERGIES, AN AMOXICILLIN ALLERGY, AND A PENICILLIN ALLERGY. CONCOMITANT PRODUCTS INCLUDED ZOLOFT (SERTRALINE). ON (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED ONE THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP TO THE MIDDLE OF HER LOWER BACK. AFTER 6 HOURS, SHE TOOK OFF THE PRODUCT AS IT FELT LIKE IT WAS BURNING HER BACK, SHE HAD A BURNING SENSATION, AND IT WAS PAINFUL. SHE REPORTED THE WRAP BURNED HER AND THERE WAS REDNESS. SHE HAD 2 BLISTERS ON HER BACK, ONE OF WHICH POPPED AND HAD A SCAB ON IT. THE BLISTERS WERE APPROXIMATELY A HALF INCH IN DIAMETER AND THE OTHER ONE WAS ABOUT 2 INCHES IN DIAMETER. THE SIZE OF THE BURN WAS THE SIZE OF THE HEAT WRAP AND IT WAS LOCATED WHERE SHE APPLIED THE PRODUCT. FOR TREATMENT, SHE USED ANTIBIOTIC CREAM AND PUT A LARGE BAND-AID OVER THE AREA. THE CONSUMER HAD A NURSE THAT HELPED HER APPLY THE BANDAGE TO HER BACK. AS OF (B)(6) 2021, THE CONSUMER HAD NOT NOTIFIED HER DOC

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11871525 ↗
• InjuryApr 2, 2021Off-Label Use; Off-Label Use

  ON 15-MAR-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6)-YEAR OLD FEMALE (ETHNICITY WAS NOT SPECIFIED) WHO WAS USING THERMACARE LOWER BACK AND HIP 8 HOUR L/XL 2 COUNT (LOT NUMBER: AR5202, EXPIRATION DATE: APRIL-2022). MEDICAL HISTORY INCLUDED ASTHMA, AN ALLERGY TO BACTRIM (TRIMETHOPRIM/SULFAMETHOXAZOLE), AND A "PINCHED NERVE" IN THE BACK WHICH THE CONSUMER HAD SURGERY SCHEDULED FOR. THE CONSUMER DID NOT USE CONCOMITANT MEDICATIONS OR SUPPLEMENTS. ON AN UNSPECIFIED DATE REPORTED AS "FOR A FEW MONTHS", THE CONSUMER USED THERMACARE LOWER BACK AND HIP 8-HOUR L/XL 2 COUNT AT AN UNSPECIFIED FREQUENCY OF APPLICATION. ON (B)(6) 2021, THE CONSUMER USED THE PRODUCT FOR HER PINCHED NERVE AND LEFT THE PRODUCT ON FOR 12 CONTINUOUS HOURS. A FEW MINUTES AFTER APPLICATION, THE CONSUMER EXPERIENCED ITCHING. APPROXIMATELY AFTER 12 HOURS, WHEN SHE TOOK IT OFF, SHE HAD A 2ND DEGREE BURN AT THE APPLICATION SITE. SHE HAD DISCONTINUED THE PRODUCT SINCE THE INCIDENT. FOR TREATMENT, THE CONSUMER APPLIED ALOE WHICH HELPED. ON (B)(6) 2021, THE CONSUMER'S BURN WAS NOTED TO BE HEALING AND SHE HAD NOT SOUGHT CONSULTATION WITH A MEDICAL DOCTOR. ON (B)(6) 2021, F

  Patient problems: Itching Sensation; Partial thickness (Second Degree) Burn

  MAUDE report 11609595 ↗
• MalfunctionMar 23, 2021Therapeutic or Diagnostic Output Failure; Excessive Heating; Therapeutic or Diagnostic Output Failure; Excessive Heating

  EVENT VERBATIM [PREFERRED TERM] HER BACK FELT LIKE IT WAS ON FIRE/HAS A LITTLE BURNING [BURNING SENSATION], A LITTLE BLOTCHY [RASH MACULAR], FELT TOO HOT [DEVICE ISSUE], STILL HAS A LOT OF BACK PAIN [DEVICE INEFFECTIVE], NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A (B)(6) FEMALE PATIENT RECEIVED THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER DP0466, EXPIRATION DATE FEB2023, UPC/UDI NUMBER (B)(4), ON (B)(6) 2021 AT AS NEEDED FOR BACK PAIN. MEDICAL HISTORY WAS NONE. THERE WERE NO CONCOMITANT MEDICATIONS. ON (B)(6) 2021, THE PATIENT WORE THERMACARE FOR THE BACK OVER CLOTHES AND HER BACK FELT LIKE IT WAS ON FIRE. SHE WORE IT FOR FOUR HOURS BUT THERE WAS NO REDNESS IT JUST FELT TOO HOT THEN SHE TOOK IT OFF. SHE WAS USING THERMACARE TODAY ((B)(6) 2021) FOR THE FIRST TIME. SHE WAS GOING BACK TO WORK AND STILL HAD A LOT OF BACK PAIN ON (B)(6) 2021. SHE THOUGHT IT WOULD HELP HER SINCE SHE ONLY WORKED IN THE MORNING BUT SHE COULDN'T KEEP IT ON THE FULL TIME. SHE STILL HAD A LITTLE BURNING; IT WAS NOT RED BUT IT WAS A LITTLE BLOTCHY BUT SHE ONLY JUST TOOK IT OFF ON (B)(6) 2021. SHE ADDED TAKING THE PRODUCT OFF MADE IT FEEL BETTER. SHE

  Patient problems: Pain; Rash; Skin Burning Sensation

  MAUDE report 11555576 ↗
• InjuryMay 15, 2020Use of Device Problem; Use of Device Problem

  EVENT VERBATIM [PREFERRED TERM] . SHE DID READ THE USAGE INSTRUCTIONS/SHE CHECKED HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE. WHEN ASKED HOW OFTEN DID YOU CHECK, SHE SAID WHEN THE BLISTER WAS FOUND [INTENTIONAL DEVICE MISUSE], BLISTERED HER SKIN/LIKE A BURN/BLISTER [BURNS SECOND DEGREE], MAYBE SOMETHING WAS DEFECTIVE IN THAT ONE CIRCLE [DEVICE ISSUE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HERSELF. A 61-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER CM3233, EXPIRATION DATE 31JUL2022, UPC NUMBER: 305733010037, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM (B)(6) 2020 TO (B)(6) 2020 ONE WRAP APPLIED ONCE FOR GENETIC BACK ISSUES AND CURVATURE OF SPINE. SHE WAS NOT PREGNANT. MEDICAL HISTORY INCLUDED OSTEOARHTIS AND BONE SPURS IN HER HIP AND LEFT SHOULDER, SHE TOOK PAIN MEDS; DEPRESSION; SHE QUIT SMOKING A COUPLE YEARS AGO AND PUT ON WEIGHT; ONGOING POST-MENOPAUSAL. THE PATIENT DENIED BELOW CONDITIONS: DIABETES, POOR CIRCULATION; HEART DISEASE, DIFFICULTY FEELING HEAT OR PAIN ON YOUR SKIN; RHEUMATOID ARTHRITIS; DECREASED SENSATION; NEUROPATHY. SHE CLASSIFIED HER SKIN

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

  MAUDE report 10061893 ↗
• InjuryMar 24, 2020Use of Device Problem; Device Markings/Labelling Problem

  EVENT VERBATIM [PREFERRED TERM] READ THE USAGE INSTRUCTIONS/DID NOT CHECK HER SKIN UNDER THE PRODUCT WHILE WEARING THERMACARE/SHE ATTACHED THE ADHESIVE TO: BODY [INTENTIONAL DEVICE MISUSE], USED EXPIRED WRAP [EXPIRED DEVICE USED], THREE BLISTERS ON BACK/FELT SOMETHING REALLY HOT WHILE USING WRAP/ONE SPOT WAS STILL BURNING HER PRETTY BAD/HURTING REALLY BAD [BURNS SECOND DEGREE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM TWO CONTACTABLE CONSUMERS (ONE WAS PATIENT). AN 89-YEAR-OLD NON-PREGNANT FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER F26176, EXPIRATION DATE APR2014, UDI#: (B)(4) , VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION ON (B)(6) 2020 (REPORTED AS "(B)(6) 2020", PENDING CLARIFICATION) APPLIED TO LOWER BACK FOR 6 HOURS FOR BACKACHE. MEDICAL HISTORY INCLUDED STROKE (2 STROKES SINCE THE END OF 2017), MACULAR DEGENERATION FROM 2016 AND ONGOING, RHEUMATOID ARTHRITIS (SINCE AGE 17), ONGOING PSORIATIC ARTHRITIS, HYSTERECTOMY (SINCE AGE 28), NEUROPATHY, POOR CIRCULATION, NECK PAIN AND ONGOING POST-MENOPAUSAL. THE PATIENT WAS CURRENTLY UNDER THE CARE OF A PHYSICIAN FOR ONGOING HIGH BLOOD PRESSURE AND SHE SAW A HEART AND ARTH

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

  MAUDE report 9874007 ↗