ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & Hip (UDI 00305733010020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00305733010020), received between Oct 31, 2019 and May 11, 2022 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2022Leak/Splash; Leak/Splash

  ON (B)(6) 2022, A SPONTANEOUS REPORT WAS RECEIVED FROM THE UNITED STATES VIA EMAIL FROM A CONSUMER WHO OBTAINED A THERMACARE LOWER BACK AND HIP 8HR SM/M HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, AFTER OPENING THE BOX OF HEAT WRAPS, THE CONSUMER NOTICED THAT THE PRODUCT WAS STAMP-CUT INCORRECTLY. THE HEAT WRAP WAS STILL PACKAGED AND WHEN THE CONSUMER OPENED THE PACKAGE THE CHEMICAL WAS LEAKING OUT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14366042 ↗
• InjuryFeb 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA EMAIL REGARDING A MALE (AGE NOT REPORTED) WHO USED A THERMACARE HEAT WRAP. MEDICAL HISTORY INCLUDED PAIN. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED A THERMACARE HEAT WRAP (LOT NUMBER AND EXPIRATION DATE NOT PROVIDED). ON AN UNSPECIFIED DATE, AFTER USING THE PRODUCT, THE CONSUMER EXPERIENCED BLISTERS. INSTEAD OF RELIEF HE WAS IN MORE PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 13515757 ↗
• InjurySep 24, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 02-SEP-2021, A REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A CONSUMER REGARDING A (B)(6) FEMALE WHO USED THERMACARE LOWER BACK AND HIP 8HR HEAT WRAP. MEDICAL HISTORY INCLUDED AN ALLERGY TO PENICILLIN. SHE WAS REPORTED TO BE HEALTHY. NO CONCOMITANT PRODUCTS WERE USED. ON APPROXIMATELY (B)(6) 2021 (ALSO REPORTED AS 2 WEEKS AGO), THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HR HEAT WRAP (LOT NUMBER: DA2950, EXPIRATION DATE: 21-AUG-2022) TO HER BACK FOR AN UNSPECIFIED INDICATION. WHEN SHE REMOVED THE WRAP FROM HER BACK, SHE NOTICED HER SKIN WAS ITCHING AND SHE HAD A BURNING SENSATION. SHE EXPERIENCED A RASH THAT APPEARS WHEN SHE IS OUTSIDE IN THE HEAT AND WHEN SHE SHOWERS. THE AREA DOES NOT ALWAYS BOTHER HER UNLESS SHE IS EXPOSED TO INCREASED TEMPERATURES. SHE CONFIRMED THE AFFECTED AREA WAS AT THE APPLICATION SITE OF THE DEVICE. SHE COULD NOT REMEMBER IF THE WRAP WAS INTACT WHEN SHE REMOVED IT. ON (B)(6) 2021, SHE VISITED HER DOCTOR, AND SHE BROUGHT THE DEVICE WITH HER TO THE APPOINTMENT. THE DOCTOR PRESCRIBED A TOPICAL STEROID AND ADVISED THEM THAT THIS MIGHT NOT GO AWAY. AS OF (B)(6) 2021, HER SYMPTOMS WERE ONGOING, AND SHE DID NOT HAVE ANY FO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Itching Sensation; Rash; Skin Burning Sensation

  MAUDE report 12526517 ↗
• InjuryAug 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA EMAIL REGARDING A CONSUMER (GENDER NOT REPORTED) WHO USED AN UNSPECIFIED THERMACARE LOWER BACK AND HIP THERAPY HEAT WRAP (LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED) FOR BACK PAIN. MEDICAL HISTORY INCLUDED BACK PAIN. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2021, REPORTED AS OVER A WEEK AGO (RELATIVE TO (B)(6) 2021), THE CONSUMER TOPICALLY APPLIED ONE UNSPECIFIED THERMACARE LOWER BACK AND HIP THERAPY HEAT WRAP. FURTHER INFORMATION ON PRODUCT DETAILS AND DETAILS OF HOW THE CONSUMER USED F THE PRODUCT WERE NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2021, AFTER USING THE PRODUCT, THE CONSUMER EXPERIENCED A BLISTER. AS OF (B)(6) 2021, THE BLISTER HAD NOT HEALED AND HURT. FOLLOW UP ATTEMPTS WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blister; Pain

  MAUDE report 12267606 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED ON 29-MAY-2021 VIA EMAIL FROM CONSUMER REGARDING A (B)(6) YEAR-OLD FEMALE. THE CONSUMER APPLIED THE DEVICE ON (B)(6) 2021 AT AROUND 1130 TO HER BACK AND BELLY AND REPORTING THAT THE DEVICE FELT WARM/NICE AND SHE DID NOT FEEL ANY BURNING OR ITCHING. THE CONSUMER BEGAN FEELING UNCOMFORTABLE WITH DEVICE AROUND 1800 AFTER WORK. UPON REMOVAL OF THE DEVICE, THE CONSUMER FOUND BLISTERS AND SKIN PEELING AT APPLICATION SITE ON BACK. SHE ALSO REPORTS PAIN AT APPLICATION SITE WHERE THE SITE TOUCHED HER CLOTHING. SHE REPORTS A TOTAL WEAR TIME OF ABOUT SEVEN HOURS. THE OUTCOMES OF EVENTS WERE UNKNOWN AT THE TIME OF REPORT. FOLLOW UP ATTEMPTS WERE MADE TO CONTACT CONSUMER BUT WERE UNSUCCESSFUL.

  Patient problems: Blister; Pain; Peeling

  MAUDE report 12052060 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORT WAS PROVIDED TO BRIDGES CONSUMER HEALTHCARE ON 28-MAY-2021, BY ANGELINI S.P.A. THE VERBATIM OF THE REPORT IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 17-MAY-2021 FROM A PATIENT THROUGH DIAMED ((B)(6)). THIS CASE REPORT CONCERNS A MALE PATIENT (AGE UNKNOWN) WITH NO RELEVANT MEDICAL HISTORY, WHO APPLIED THERMACARE WAERMEAUFLAGEN BEI RÜCKENSCHMERZEN (THERMACARE LOWER BACK AND HIP BATCH NUMBER DX6580, EXPIRY DATE APR-2023) VIA TOPICAL ROUTE FOR BACK PAIN, ON (B)(6) 2021. CONCOMITANT MEDICATION(S): UNKNOWN. ON AN UNKNOWN DATE IN (B)(6) 2021, AFTER THERMACARE WAERMEAUFLAGEN BEI RÜCKENSCHMERZEN INITIATION, THE PATIENT EXPERIENCED BURN. AFTER USE (DURATION UNKNOWN) THE PATIENT SUFFERED BURNS. IN THE MORNING OF (B)(6) 2021 THE PATIENT EXPERIENCED SO MUCH PAIN AND NAUSEA THAT HE FAINTED. THE PATIENT STATED THAT HE WILL CONSULT A DOCTOR TO ASSESS THE BURN MARKS. IT IS UNKNOWN IF ANY ACTION WAS TAKEN WITH THERMACARE WAERMEAUFLAGEN BEI RÜCKENSCHMERZEN. THE PATIENT DID NOT RECEIVE TREATMENT FOR THIS EVENT. OUTCOME: UNKNOWN. THE REPORTER ASSESSED THIS REPORT AS SERIOUS AND DIDN'T PROVIDE CAUSAL RELATIONS

  Patient problems: Burn(s)

  MAUDE report 11939791 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating

  ON (B)(6) 2021, A SPONTANEOUS CASE FROM THE (B)(6) WAS RECEIVED VIA A (B)(6) AND (B)(6) REGARDING A FEMALE CONSUMER WHO USED THERMACARE LOWERBACK AND HIP 8HR S/M 2CT HEAT WRAP. MEDICAL HISTORY AND USE OF CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE THE CONSUMER USED THE THERMACARE LOWERBACK AND HIP 8HR S/M 2CT HEAT WRAP (LOT AND EXPIRATION DATE WERE NOT PROVIDED) FOR AN UNSPECIFIED INDICATION. THE CONSUMER'S MOTHER REPORTED THAT THE PRODUCT SEVERELY BURNT HER STOMACH WHEN SHE PEELED THEM BACK. THE CONSUMER HAD TO GO TO HER GP (GENERAL PRACTITIONER) AND HAVE TREATMENT FOR HER BURNS. THE HEAT PADS TOOK A NUMBER OF LAYERS OF HER SKIN OFF. FURTHER INFORMATION IS NOT EXPECTED AS CONTACT INFORMATION FOR THE REPORTER WAS NOT PROVIDED.

  Patient problems: Burn(s); Skin Tears

  MAUDE report 11863352 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) RECEIVED THE CASE ON 06-MAY-2021. THE REPORT WAS A SPONTANEOUS REPORT FROM GERMANY. THE VERBATIM OF THE REPORT FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 23-APR-2021 FROM A PHARMACIST THROUGH DIAMED (DE1316). THIS CASE REPORT CONCERNS A FEMALE PATIENT (OVER 50 YEARS OF AGE) WITH NO RELEVANT MEDICAL HISTORY, WHO APPLIED THERMACARE LOWER BACK AND HIP (BATCH NUMBER ED7069, EXPIRY DATE UNKNOWN) FOR UNKNOWN INDICATION. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON UNKNOWN DATE AFTER THERMACARE LOWER BACK AND HIP INITIATION, THE PATIENT EXPERIENCED BURN BLISTER. OUTCOME: BURN BLISTER: UNKNOWN. THE REPORTER ASSESSED THIS REPORT AS SERIOUS AND DIDN'T PROVIDE A CAUSALITY ASSESSMENT FOR THE EVENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11825850 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 28-APR-2021, THE CASE WAS RECEIVED FROM ANGELINI S.P.A. THE REPORT CONSISTED OF A SPONTANEOUS REPORT FROM AUSTRIA WHICH WAS RECEIVED BY ANGELINI S.P.A ON 15-APR-2021. THE VERBATIM OF THE REPORT WAS AS FOLLOWS: THIS CASE REPORT CONCERNS AN ADULT FEMALE PATIENT (AGE BETWEEN 40 AND 50), WHO APPLIED THERMACARE LOWER BACK AND HIP (BATCH NUMBER X96240, EXPIRY DATE UNKNOWN) FOR UNKNOWN INDICATION. CONCOMITANT MEDICATIONS: UNKNOWN. MEDICAL HISTORY: UNKNOWN. AFTER THERMACARE LOWER BACK AND HIP INITIATION, THE PATIENT EXPERIENCED THERMAL BURN. CUSTOMER RETURNED THE EMPTY PACK TO THE PHARMACY AND CLAIMED SHE GOT BURNS (BLISTERS). ACCORDING TO CUSTOMER PLASTER WAS WORN ON BARE SKIN, NO CREMES HAVE BEEN APPLIED UNDERNEATH AND IT HAS NOT BEEN WORN OVER NIGHT. NO CONTACT DETAILS FOR CUSTOMER ARE AVAILABLE. THE OUTCOME WAS REPORTED AS UNKNOWN. THE REPORTER ASSESSED THIS REPORT AS NOT SERIOUS AND THE COMPANY UPGRADED THE CASE TO SERIOUS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11793476 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING CASE WAS RECEIVED VIA (B)(6) . ON (B)(6) 2021 VIA PFIZER. THIS IS A FOLLOW UP REPORT FOR THE PREVIOUSLY PFIZER SUBMITTED 30 DAY REPORT CASE ((B)(4) ) DUE TO THE PRODUCT BEING ACQUIRED BY BRIDGES CONSUMER HEALTHCARE. THE ORIGINAL REPORT FROM THE PREVIOUS PFIZER SUBMISSION INCLUDED THE FOLLOWING: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PARENT OF PATIENT) VIA ANGELINI PHARMA REGARING A PATIENT FROM (B)(6) . A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER CW8013, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT GOT BURN BLISTERS AFTER USING A PATCH. THE ACTION TAKEN IN RESPONSE TO THE EVENT(S) FOR THERMACARE HEATWRAP AND THE CLINICAL OUTCOME OF THE EVENT WERE UNKNOWN. ON (B)(6) 2021, THE PRODUCT QUALITY COMPLAINT GROUP PROVIDED THE FOLLOWING INVESTIGATION RESULTS THAT YIELDED NO PRODUCT QUALITY ISSUES. THE FOLLOW UP REPORT THAT ANGELINI S.P.A. PROVIDED CONSISTED OF THE FOLLOWING: ON 30-MAR-2021

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11746091 ↗
• InjuryNov 9, 2020Use of Device Problem; Use of Device Problem

  EVENT VERBATIM [PREFERRED TERM]. TERRIBLE RASH ON HER ARM/THE RASH IS UNDER THE SIDE OF HER UPPER ARM [RASH], SHE THINKS IT WAS THE LATEX PART. MAYBE SHE IS ALLERGIC TO IT. [RUBBER SENSITIVITY], HURTS/PAINFUL [PAIN], IT WAS RED AND THERE IS A CIRCLE AROUND IT. [ERYTHEMA], IT HAS RED DOTS [RASH MACULAR], ONE ON HER STOMACH FOR HER CRAMPS AND ONE ON HER ARM/NECK FOR HER DISLOCATED SHOULDER [DEVICE USE ISSUE], NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A 45-YEAR-OLD FEMALE PATIENT STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER AR5202, EXPIRATION DATE APR2022, UDI#: (B)(4), FROM (B)(6) 2020 AT AN UNKNOWN FREQUENCY FOR PERIOD CRAMPS AND A DISLOCATED SHOULDER. MEDICAL HISTORY INCLUDED ONGOING BIPOLAR DISORDER. CONCOMITANT MEDICATION INCLUDED HALOPERIDOL (HALDOL) 5 MG TABLET FROM (B)(6) 2020 AND ONGOING, ARIPIPRAZOLE 20 MG TABLET FROM (B)(6) 2020 AND ONGOING AND GABAPENTIN 400 MG CAPSULE AND 800 MG TABLET FROM 1992 (STARTED 28 YEARS AGO) AND ONGOING, ALL FOR BIPOLAR DISORDER. FOR GABAPENTIN, THE PATIENT SAID SHE GOT HER MEDICATION IN A PHARMACY BOTTLE THAT WAS NOT SEALED- SHE SAID IT WAS IN A BOTTLE WHERE THEY COUNT

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Pain; Rash

  MAUDE report 10809858 ↗
• MalfunctionOct 29, 2020Adverse Event Without Identified Device or Use Problem; Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating

  GETS SO HOT SHE WOULD SWEAT [HYPERHIDROSIS],THE ONE FOR THE BACK SHE USED GOT REALLY HOT; WORKS SO GOOD AND GETS SO HOT SHE WOULD SWEAT [DEVICE ISSUE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER AR5202, EXPIRATION DATE MAY2022, UDI NUMBER (B)(4), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN FREQUENCY FOR HER HIP. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT REPORTED SHE BOUGHT 8 BOX OF THE BIG ONES THAT WENT AROUND THE WAIST AND THOSE WOULD GET SO HOT THEY WOULD SWEAT. THE ONE FOR THE BACK SHE USED GOT REALLY HOT, SHE USED IT FOR HER HIP. SHE WENT ON TO EXPLAIN THAT ONE WORKED SO GOOD AND GOT SO HOT SHE WOULD SWEAT. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEATWRAP WAS UNKNOWN. THE OUTCOME OF THE EVENTS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.

  Patient problems: Sweating

  MAUDE report 10755158 ↗
• InjuryDec 12, 2019Improper or Incorrect Procedure or Method

  EVENT VERBATIM [PREFERRED TERM] APPLIES PRODUCT DIRECTLY TO HER SKIN AND NOT OVER HER CLOTHES [DEVICE USE ERROR]. CASE NARRATIVE:THE INITIAL CASE WAS MISSING THE FOLLOWING MINIMUM CRITERIA: NO AE, PRODUCT COMPLAINT ONLY. UPON RECEIPT OF FOLLOW-UP INFORMATION ON (01NOV2019), THIS CASE NOW CONTAINS ALL REQUIRED INFORMATION TO BE CONSIDERED VALID. THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. THIS 77-YEAR-OLD FEMALE PATIENT (WEIGHT 177 LB, AND HEIGHT: 5'6 IN) STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (DEVICE LOT NUMBER T81951, EXPIRATION DATE 31DEC2020, UPC 305733010020, AND LOT NUMBER W92738; EXP NOV2021) FROM AN UNSPECIFIED DATE FOR BACK PAIN AND SOAR BACK. THE PATIENT MEDICAL HISTORY INCLUDED HYPERTENSION, ATRIAL FIBRILLATION, ANAL CANCER 28 YEARS AGO AND THE 28 RADIATIONS IN GROIN AREA KILLED THE NERVES, AND NEUROPATHY. CONCOMITANT MEDICATION INCLUDED: LOSARTAN STARTED OUT AT 50 MG AND NOW 25 MG AT BEDTIME FOR HYPERTENSION SINCE AT LEAST 10 YEARS; APIXABAN (ELIQUIS) 5 MG TWICE A DAY SINCE PROBABLY A YEAR AND HALF, FOR STROKE PREVENTION; FLECAINIDE AT 50 MG TWICE A DAY SINCE ONE YEAR AND HALF, FOR ATRIAL FIBRILLATION; GABAPENTIN 300 MG THREE TIMES

  Patient problems: Complaint, Ill-Defined

  MAUDE report 9458518 ↗
• MalfunctionOct 31, 2019Unintended Ejection

  EVENT VERBATIM [PREFERRED TERM] THE CHARCOAL WAS ALL OVER THE PLACE [DEVICE LEAKAGE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER M87708, EXPIRATION DATE JAN2019, UPC NUMBER: (B)(4), FROM AN UNSPECIFIED DATE AT AN UNKNOWN FREQUENCY FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT STATED THAT THE BOUGHT THE THERMACARE LOWER BACK AND HIP HEATWRAP. WHEN SHE BROKE OPEN THE FIRST PACKAGING, THE CHARCOAL WAS ALL OVER THE PLACE ON AN UNSPECIFIED DATE. SHE THEN OPENED THE OTHER ONE THAT CAME IN THE BOX, AND THAT ONE WAS THE SAME WAY; AS BAD IF NOT WORSE. SHE WAS REALLY SURPRISED. THE PATIENT STATED THAT SHE BOUGHT THEM QUITE OFTEN AND HAD NEVER HAD A PROBLEM IN THE PAST. PRODUCT WAS SEALED WHEN PURCHASED; NOTHING ABNORMAL AT ALL WITH THE PACKAGING. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS IN THE EQUIP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9259578 ↗