ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & Hip (UDI 00305733010396)Recalls & reported problems

Summary

The FDA's MAUDE database contains 196 adverse event reports that list this exact device (DI 00305733010396), received between Mar 17, 2022 and Jun 29, 2026 — classified as 172 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (147 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 196 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Insufficient Device Problem Information

  THIS SPONTANEOUS REPORT WAS RECEIVED ON 11-JUN-2026, VIA EMAIL, FROM A FEMALE CONSUMER OF UNSPECIFIED AGE IN THE USA IN ASSOCIATION WITH THERMACARE LOWER BACK AND HIP. MEDICAL HISTORY, ALLERGIES AND CONCOMITANT MEDICATIONS/SUPPLEMENTS WERE UNSPECIFIED. THE CONSUMER USED THERMACARE LOWER BACK AND HIP ON AN UNSPECIFIED DATE AND EXPERIENCED MEDICAL DEVICE SITE BURN. NO ADDITIONAL INFORMATION WAS PROVIDED. FOLLOW UP ATTEMPTS TO THE CONSUMER VIA EMAIL ON 11-JUN-2026 AND 12-JUN-2026 WERE UNSUCCESSFUL.

  Patient problems: Burn(s)

  MAUDE report 25656118 ↗
• InjuryJun 25, 2026Insufficient Device Problem Information

  ON (B)(6) 2026, THIS REPORT WAS RECEIVED FROM A CONSUMER REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN THE U.S. IN ASSOCIATION WITH A THERMACARE MENSTRUAL 8HR HEAT WRAP. ON (B)(6) 2026, THE CONSUMER TOPICALLY APPLIED A THERMACARE MENSTRUAL 8HR HEAT WRAP ON THE SKIN OF HER LOWER ABDOMEN FOR AN UNSPECIFIED INDICATION. APPROXIMATELY 3 HOURS AFTER APPLYING THE HEAT WRAP, SHE FELT A STINGING SENSATION ON HER ABDOMEN. WHEN SHE PULLED HER UNDER GARMENTS DOWN HER SKIN WAS ATTACHED TO THE HEAT WRAP. SHE FELT PAIN AND HAD TO TAKE PAIN MEDICATIONS. SHE WAS BURNED IN TWO AREAS ON HER LOWER ABDOMEN. SHE COVERED THE AREA WITH GAUZE, BANDAGES, AND OINTMENT. SHE HAD DIFFICULTY PERFORMING HER DAILY TASKS DUE TO HER ABDOMINAL PAIN FOR 4 DAYS. AS IT HEALED THE PAIN DECREASED. HER SKIN HAD BEGUN TO GROW BACK AND THE PAIN WAS LITTLE TO NONE. SHE NOTED SHE WAS PHYSICALLY AND EMOTIONALLY HARMED AND SCARRED FOR LIFE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. ATTEMPTS TO CONTACT THE CONSUMER VIA EMAIL ON (B)(6) 2026 AND (B)(6) 2026 WERE UNSUCCESSFUL.

  Patient problems: Burn(s); Emotional Changes; Pain; Peeling; Scar Tissue

  MAUDE report 25627331 ↗
• InjuryJun 11, 2026Insufficient Device Problem Information

  THIS SPONTANEOUS REPORT WAS RECEIVED ON 18-MAY-2026, VIA TELEPHONE, FROM A 62-YEAR-OLD, NONSMOKING, FEMALE CONSUMER IN THE US IN ASSOCIATION WITH THERMACARE LOWER BACK AND HIP HEAT WRAP. FOLLOW UP WAS COMPLETED WITH THE CONSUMER ON (B)(6) 2026 VIA TELEPHONE. ALL CONTACTS WILL BE TREATED AS AN INITIAL REPORT. THE CONSUMER USED THERMACARE LOWER BACK AND HIPS HEAT WRAP ON (B)(6) 2026, BY PLACING IT ON HER UPPER ARM/ELBOW, AT AROUND 2200. SHE PUT HER NIGHT SWEATER OVER THE THERMACARE, FELL ASLEEP AND WOKE UP AT 0700. THE CONSUMER EXPERIENCED ITCHING AND REMOVED THE WRAP, AND EXPERIENCED SKIN PEELING, BURNING SENSATION, REDNESS AND OOZING. SHE APPLIED TRIPLE ANTIBIOTIC OINTMENT. ON (B)(6) 2026, THE CONSUMER SAW HER DOCTOR FOR ONGOING SYMPTOMS AND WAS DIAGNOSED WITH A BURN. SHE WAS GIVEN SILVER SULFADIAZINE 1 MG CREAM FOR TREATMENT AND TOLD TO FOLLOW-UP IF SYMPTOMS PERSIST OVER 14 DAYS. THE AREA WAS HEALING BUT TAKING LONGER THAN EXPECTED. THE OOZING RESOLVED ON APPROXIMATELY ON (B)(6) 2026. SHE HAD A MILD STINGING SENSATION ON THE AREA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s); Fluid Discharge; Itching Sensation

  MAUDE report 25470200 ↗
• InjuryJun 4, 2026Insufficient Device Problem Information

  ON (B)(6) 2026, THIS REPORT WAS RECEIVED FROM A CONSUMER REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH A THERMACARE MENSTRUAL HEAT WRAP. ON AN UNSPECIFIED DATE, THE CONSUMER ATTACHED A THERMACARE MENSTRUAL HEAT WRAP TO HER UNDERWEAR AND SLEPT. AFTER AN UNSPECIFIED AMOUNT OF TIME OF WEARING THE HEAT WRAP, THE CONSUMER WOKE UP AND HAD AN OPEN SORE ON THE LOWER LEFT OF HER ABDOMEN. SHE NOTED SHE SLEPT ON HER BACK AND THERE WAS NOT ANY EXTRA PRESSURE APPLIED TO THE HEAT WRAP. FOLLOW-UP ATTEMPTS WERE UNSUCCESSFUL IN OBTAINING ADDITIONAL INFORMATION.

  Patient problems: Ulcer

  MAUDE report 25398817 ↗
• InjuryMay 27, 2026Insufficient Device Problem Information

  ON 07-MAY-2026, THIS REPORT WAS RECEIVED REGARDING A 64-YEAR-OLD MALE CONSUMER IN THE US IN ASSOCIATION WITH AN UNSPECIFIED THERMACARE HEATWRAP. ON (B)(6) 2026 AT 2000 HOURS THE CONSUMER TOPICALLY APPLIED A THERMACARE HEAT WRAP TO HIS LOWER BACK. HE APPLIED THE PRODUCT DIRECTLY TO THE SKIN ON HIS BACK AND COVERED IT WITH A SHIRT. APPROXIMATELY AT 400 AM THE NEXT MORNING HE EXPERIENCED PAIN AND TOOK OFF THE PRODUCT. HE NOTED HIS SKIN WAS BURNED ON THE LEFT SIDE OF HIS LOWER BACK. HE RINSED THE AREA, DRIED WITH A PAPER TOWEL, AND APPLIED NEOSPORIN. ON (B)(6) 2026, HE WENT TO HIS PRIMARY CARE PROVIDER AND WAS ADVISED TO CONTINUE NEOSPORIN AND NOT TO USE THE PRODUCT. AS OF (B)(6) 2026, THE PAIN AND THE BURN WERE ONGOING. THE CONSUMER ANTICIPATED HAVING SURGERY ON (B)(6) 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 25301846 ↗
• InjuryMay 8, 2026Insufficient Device Problem Information

  ON 19-APR-2026, THIS SPONTANEOUS REPORT WAS RECEIVED REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN PUERTO RICO IN ASSOCIATION WITH A THERMACARE MENSTRUAL HEAT WRAP. ON (B)(6) 2026, THE CONSUMER APPLIED A MENSTRUAL THERMACARE HEAT WRAP FOR AN UNSPECIFIED INDICATION. MEDICAL HISTORY, CONCOMITANT PRODUCTS, AND ALLERGIES WERE NOT PROVIDED. ON (B)(6) 2026, AFTER USING THE PRODUCT THE CONSUMER EXPERIENCED AN IMMEDIATE REACTION. I WAS CLARIFIED THAT SHE EXPERIENCED BURNS WITH TWO BLISTERS THAT WERE PAINFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 25127288 ↗
• InjuryMay 8, 2026Insufficient Device Problem Information

  ON 16-APR-2026, THIS SPONTANEOUS REPORT FROM THE US WAS RECEIVED REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP. ON AN UNSPECIFIED DATE THE CONSUMER APPLIED A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP TO THE BACK OF THE NECK FOR AN UNSPECIFIED INDICATION. ON AN UNSPECIFIED DATE AFTER 6 TO 7 HOURS OF PRODUCT APPLICATION, SHE HAD IRRITATION. SHE EXPERIENCED BURNS ON THE BACK OF HER NECK AND HAD SKIN DAMAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s); Localized Skin Lesion

  MAUDE report 25126336 ↗
• InjuryMay 1, 2026Insufficient Device Problem Information; Excessive Heating

  ON 08-APR-2026, THIS SPONTANEOUS REPORT FROM THE US WAS RECEIVED REGARDING A FEMALE (AGE NOT PROVIDED) CONSUMER REGARDING A THERMACARE MENSTRUAL HEAT WRAP. ON (B)(6) 2026, THE CONSUMER TOPICALLY APPLIED A THERMACARE MENSTRUAL HEAT WRAP. AFTER THREE HOURS OF APPLICATION, SHE REMOVED THE HEAT WRAP AS IT BECAME HOT. SHE EXPERIENCED A BURN AND BLISTERS ON HER SKIN. THE AREA WAS SCABBED AND CONTINUED TO LEAVE A MARK. NO ADDITIONAL INFORMATION WAS PROVIDED DESPITE FOLLOW-UP ATTEMPTS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25058958 ↗
• MalfunctionApr 29, 2026Manufacturing, Packaging or Shipping Problem

  ON 09-APR-2026, THIS SPONTANEOUS REPORT WAS RECEIVED FROM THE UNITED STATES REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH A THERMACARE LOWER BACK AND HIP HEAT WRAP. ON AN UNSPECIFIED DATE, THE CONSUMER NOTED THAT BOTTOM AND MIDDLE SECTIONS OF THE HEAT WRAP WERE UNDERFILLED. THE SUBSTANCE STARTED LEAKING OUT CAUSING MOISTURE OF SOME TYPE. SHE HAD VISIBLE MOISTURE ON HER BACK COMING FROM THE PAD. FOLLOW UP ATTEMPTS WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033291 ↗
• InjuryApr 29, 2026Insufficient Device Problem Information

  ON (B)(6) 2026, THIS REPORT WAS RECEIVED REGARDING A 73-YEAR-OLD FEMALE CONSUMER IN THE US IN ASSOCIATION WITH A THERMACARE LOWER BACK AND HIP HEAT WRAP. APPROXIMATELY AT NOON ON (B)(6) 2026, THE CONSUMER APPLIED A THERMACARE LOWER BACK AND HIP HEAT WRAP TO HER BACK FOR AN UNSPECIFIED INDICATION. A FEW HOURS AFTER USING THE PRODUCT, THE CONSUMER EXPERIENCED IRRITATION OR PAIN IN THE AREA. THE PRODUCT WAS REMOVED AND THE AREA WAS RED AND IT LOOKED LIKE A CHEMICAL BURN. SHE NOTED SHE EXPERIENCED BURNS ON HER LOWER BACK WITH BURN PATCHES WITH BLISTERS DEVELOPING LATER THAT DAY. FOR TREATMENT SHE USED A BURN CREAM. AT THE TIME OF THE REPORT, THE BLISTERS WERE STILL PRESENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 25033245 ↗
• InjuryApr 17, 2026Insufficient Device Problem Information

  ON 20-MAR-2026, THIS SPONTANEOUS REPORT WAS RECEIVED REGARDING A FEMALE (AGE NOT PROVIDED) CONSUMER IN ASSOCIATION WITH AN UNSPECIFIED THERMACARE HEAT WRAP. ON AN UNSPECIFIED DATE THE CONSUMER APPLIED A THERMACARE HEAT WRAP FOR AN UNSPECIFIED INDICATION. ON AN UNSPECIFIED DATE AFTER STARTING THE PRODUCT, THE CONSUMER EXPERIENCED A BURN ON THE SKIN. SHE USED THE PRODUCT FOR ABOUT AN HOUR BEFORE TAKING THE PRODUCT OFF. SHE HAD TO GO TO URGENT CARE FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 24909886 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  ON 03-APR-2026, ANGELINI S.P.A. PROVIDED THE FOLLOWING REPORT TO BRIDGES CONSUMER HEALTHCARE. ANGELINI S.P.A. RECEIVED THE REPORT ON 23-MAR-2026. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER: (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 23/MAR/2026 FROM A CONSUMER THROUGH DIAMED (DE7352). THIS CASE REPORT CONCERNS A 28 YEAR(S) OLD FEMALE PATIENT, WHO APPLIED THERMACARE NECK SHOULDER WRIST (BATCH NUMBER: GA1628, EXPIRY DATE: UNKNOWN) USED FOR UNKNOWN INDICATION. MEDICAL HISTORY INCLUDED: UNKNOWN. CONCOMITANT PRODUCTS INCLUDED: UNKNOWN. ON UNKNOWN DATE, AFTER THERMACARE NECK SHOULDER WRIST, THE PATIENT EXPERIENCED BURN BLISTER, APPLICATION SITE INFLAMMATION. ON AN UNKNOWN DATE, AFTER HAVING USED THERMACARE FOR APPROXIMATELY 2 HOURS DURING WORK (THE PATCH WAS NOT WORN DIRECTLY ON THE SKIN BUT ABOVE A TURTLENECK JUMPER), THE PATIENT EXPERIENCED BURN BLISTER, WHICH WAS CONSIDERED SERIOUS AND APPLICATION SITE INFLAMMATION, WHICH WAS CONSIDERED NOT SERIOUS. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT YET RECOVERED. THE INFLAMMATION AREA HAD TO BE TREATED WITH ANTIBIOTICS. OUTCOME: BURN BLISTER: UNKNOWN, APPLICATION SITE INFLAMMATION: UNKNOWN. THE ACTION TAKEN IN

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

  MAUDE report 24832637 ↗
• InjuryApr 7, 2026Insufficient Device Problem Information

  THIS REPORT WAS RECEIVED ON 10-FEB-2026 WHICH REGARDED A 50-YEAR-OLD FEMALE IN ASSOCIATION WITH A THERMACARE LOWER BACK AND HIP HEAT WRAP. ON 13-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED VIA THE FDA (MW5183932) AND THE REPORT WAS ASSESSED AS A REPORTABLE DEVICE COMPLAINT. ON (B)(6) 2026, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP HEAT WRAP TO THE LEFT LOWER SIDE OF HER BACK FOR BACK PAIN. AFTER APPLYING THE HEAT WRAP, SHE FELT A WARM SENSATION BUT NOT BURNING WHILE USING THE PRODUCT. AFTER 6 HOURS OF APPLICATION, THE WRAP WAS REMOVED AND SHE NOTED PAINFUL RED MARKS IN THE SHAPE OF THE HEATING CELLS. THE PAIN MADE IT DIFFICULT FOR HER TO SLEEP. ON (B)(6) 2026, SMALL BLISTERS DEVELOPED. SHE APPLIED ALOE VERA TO THE AREA. THE REACTION WORSENED OVER THE NEXT FEW DAYS; THE REDNESS AND BLISTERS SPREAD DOWN TO HER UPPER LEFT THIGH. ON (B)(6) 2026, SHE WENT TO AN EMERGENCY ROOM (ER). THE ER STAFF STATED SHE DID NOT EXPERIENCE A BURN. SHE WAS DIAGNOSED WITH CONTACT DERMATITIS. SHE WAS PRESCRIBED CORTISONE CREAM THREE TIMES DAILY FOR TWO WEEKS. IT WAS LATER REPORTED BY THE CONSUMER THAT THE PRODUCT CAUSED SEVERE BURNS AND BLISTERS. CORTISONE IMPROVED HER SYMPTOMS. ON

  Patient problems: Contact Dermatitis; Full thickness (Third Degree) Burn

  MAUDE report 24802171 ↗
• InjuryApr 7, 2026Insufficient Device Problem Information

  THIS REPORT WAS RECEIVED ON 12-MAR-2026 REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH THERMACARE NECK/SHOULDER/WRIST HEAT WRAP. ON AN UNSPECIFIED DATE, THE CONSUMER APPLIED THE PRODUCT AND THEN RESTED ON HER RECLINER. AFTER USING THE PRODUCT, SHE EXPERIENCED A BURN ON HER SKIN. THE CONSUMER DECLINED TALKING TO MEDICAL. SHE NOTED THAT THE PACKAGING COULD BE A LITTLE CLEARER FOR OLDER USERS.

  Patient problems: Burn(s)

  MAUDE report 24802144 ↗
• InjuryMar 19, 2026Insufficient Device Problem Information

  ON 01-MAR-2026, THIS SPONTANEOUS REPORT WAS RECEIVED REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH AN UNSPECIFIED THERMACARE HEAT WRAP. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED AN UNSPECIFIED THERMACARE HEAT WRAP FOR AN UNSPECIFIED INDICATION. AFTER USING THE PRODUCT FOR AN UNSPECIFIED TIME, THE CONSUMER EXPERIENCED A BURN ON THE BACK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 24643053 ↗
• InjuryMar 19, 2026Insufficient Device Problem Information

  ON 01-MAR-2026, THIS SPONTANEOUS REPORT WAS RECEIVED REGARDING AN 85-YEAR-OLD FEMALE CONSUMER IN ASSOCIATION WITH AN UNSPECIFIED THERMACARE LOWER BACK AND HIP HEAT WRAP. APPROXIMATELY ON 01-FEB-2026, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP HEAT WRAP FOR AN UNSPECIFIED INDICATION. AFTER 4 HOURS OF USING THE PRODUCT, SHE EXPERIENCED BURNING. TWO HOURS LATER HER DAUGHTER TOOK OFF THE HEAT WRAP. THE AREA WAS NOTED TO HAVE A BURN. FOR TREATMENT SHE USED ALOE VERA, VITAMIN E, AND A ANTIBIOTIC CREAM FOR 3 WEEKS. AS OF 04-MAR-2026, THE AREA WAS IMPROVING BUT MARKS STILL REMAINED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 24643014 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  ANGELINI S.P.A. PROVIDED THE REPORT TO BRIDGES CONSUMER HEALTHCARE ON (B)(6) 2026. ANGELINI S.P.A. RECEIVED THE REPORT ON (B)(6) 2026. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON (B)(6) 2026 FROM A PHARMACIST THROUGH DIAMED (DE7119). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE NOT REPORTED), WHO APPLIED A THERMACARE NECK SHOULDER WRIST (BATCH NUMBER: UNKNOWN, EXPIRY DATE: UNKNOWN) USED FOR UNKNOWN INDICATION. MEDICAL HISTORY INCLUDED: UNKNOWN. CONCOMITANT PRODUCTS INCLUDED: UNKNOWN. ON UNKNOWN DATE, AFTER THERMACARE NECK SHOULDER WRIST, THE PATIENT EXPERIENCED THERMAL BURN. THE REPORTER STATED THAT THEY HAD A PATIENT (FEMALE) IN OCTOBER WHO HAD PURCHASED THERMACARE NECK PATCHES FROM THE PHARMACY. THE PATIENT STATED THAT SHE USUALLY USES THERMACARE REGULARLY, BUT THIS TIME SHE SUFFERED BURNS FROM IT. OUTCOME: THERMAL BURN: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE NECK SHOULDER WRIST WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE NECK SHOULDER WRIST MENTIONS THAT THERMAL BURN COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE. DECHALLENGE

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24576377 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  ON (B)(6) 2026, THIS SPONTANEOUS REPORT WAS RECEIVED REGARDING A 31-YEAR-OLD FEMALE IN ASSOCIATION WITH AN UNSPECIFIED THERMACARE HEAT WRAP. ON AN UNSPECIFIED DATE IN (B)(6) 2025, THE CONSUMER WOULD APPLY A THERMACARE MENSTRUAL 8 HR HEAT WRAP TO HER LOWER STOMACH AT NIGHT FOR 4 HOURS AT A TIME. SHE WOULD ALSO APPLY AN UNSPECIFIED THERMACARE HEAT WRAP DURING THE DAY FOR 4 HOURS. ON (B)(6) 2026, IT WAS IDENTIFIED THIS REPORT WAS ASSOCIATED TO THE BELOW RELATED REPORT. APPROXIMATELY AFTER 3 TO 4 DAYS OF USING THE MENSTRUAL HEAT WRAPS DURING THE NIGHT AND THE UNSPECIFIED THERMACARE HEAT WRAP SHE NOTICED REDNESS, IRRITATION, ITCHING, SWELLING, AND A RASH. THE RASH BELOW THE STOMACH AND ABOVE THE VAGINAL AREA. SHE USED COCONUT OIL TO HELP WITH THE SYMPTOMS. SHE CONTINUED USING THE PRODUCTS. APPROXIMATELY 2 TO 3 WEEKS AFTER USING THE PRODUCTS SHE EXPERIENCED BURNS WHICH RESULTED IN BLISTERS WHICH BURST. APPROXIMATELY ON (B)(6) 2026, THE CONSUMER WENT TO AN EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH A CONTUSION. THE CONSUMER WANTED TO OBTAIN A SECOND OPINION. ON (B)(6) 2026, THE APPLICATION AREA WAS BLACK, A SCAR WAS NOTICEABLE, AND THE BURNS WERE STILL HEALING. AS OF (B)(6) 2026, THE AREA

  Patient problems: Bruise/Contusion; Partial thickness (Second Degree) Burn; Scar Tissue; Skin Discoloration

  MAUDE report 24532958 ↗
• InjuryFeb 25, 2026Insufficient Device Problem Information

  ON 31-JAN-2026, THIS SPONTANEOUS REPORT WAS RECEIVED REGARDING A 36-YEAR-OLD FEMALE CONSUMER IN ASSOCIATION WITH AN UNSPECIFIED THERMACARE HEATWRAP. ON (B)(6) 2026, THE CONSUMER TOPICALLY APPLIED A THERMACARE HEAT WRAP TO HER NECK FOR AN UNSPECIFIED INDICATION. SHE APPLIED THE PRODUCT AND THE PRODUCT DID NOT STICK. SUBSEQUENTLY, SHE SECURED THE PRODUCT TO HER NECK WITH TAPE. AFTER THREE HOURS, SHE REMOVED THE PRODUCT AND NOTED SHE HAD A BURN MARK. THE BURN WAS DESCRIBED AS HAVING RED AND BLACK MARKS THAT LOOKED LIKE A CURLING IRON TOUCHED HER SKIN. SHE APPLIED VASELINE TO THE AFFECTED AREA AND THE AREA WAS IMPROVING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 24446166 ↗
• InjuryFeb 19, 2026Insufficient Device Problem Information

  THIS SPONTANEOUS REPORT WAS RECEIVED ON 23-JAN-2026 FROM THE UNITED STATES REGARDING A FEMALE (AGE NOT PROVIDED) CONSUMER IN ASSOCIATION WITH A THERMACARE LOWER BACK& HIP HEAT WRAP. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK & HIP HEAT WRAP FOR BACK AND HIP PAIN. ON AN UNSPECIFIED DATE, AFTER USING THE PRODUCT FOR AN UNSPECIFIED PERIOD OF TIME, THE CONSUMER EXPERIENCED A BURN. THE BURN WAS PAINFUL. THE AREA WAS RAISED AND OOZING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burn(s); Localized Skin Lesion; Pain

  MAUDE report 24396566 ↗
• InjuryFeb 13, 2026Insufficient Device Problem Information

  ON 15-JAN-2026, THIS SPONTANEOUS REPORT WAS RECEIVED REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH A THERMACARE LOWER BACK AND HIP HEAT WRAP. ON AN UNSPECIFIED DATE, THE CONSUMER APPLIED A THERMACARE LOWER BACK AND HIP HEAT WRAP APPLIED ON HER RIBS FOR MUSCLE PAIN. AFTER APPLYING THE HEAT WRAP, THE CONSUMER EXPERIENCED A BURN. SHE NOTED SHE DID NOT FEEL THAT MUCH HEAT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 24333663 ↗
• InjuryFeb 11, 2026Insufficient Device Problem Information

  THIS SPONTANEOUS REPORT WAS RECEIVED ON 15-JAN-2026 REGARDING A MALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH AN UNSPECIFIED THERMACARE HEAT WRAP. ON AN UNSPECIFIED DATE, THE CONSUMER STARTING USING A THERMACARE HEAT WRAP. AFTER USING THE PRODUCT, THE CONSUMER NOTED IT BURNT HIS SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 24317084 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  ANGELINI S.P.A. PROVIDED THIS SPONTANEOUS REPORT TO BRIDGES CONSUMER HEALTHCARE ON 15-JAN-2026. ANGELINI S.P.A. RECEIVED THE REPORT ON 02-JAN-2026. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 02/JAN/2026 FROM A PHARMACIST THROUGH DIAMED (B)(4). THIS CASE REPORT CONCERNS A FEMALE PATIENT (APPROXIMATELY 40 YEARS OLD), WHO APPLIED THERMACARE NECK SHOULDER WRIST 12 HOURS (LOT NUMBER: UNKNOWN, EXPIRATION DATE: UNKNOWN), USED FOR UNKNOWN INDICATION. CONCOMITANT MEDICATION(S): UNKNOWN. MEDICAL HISTORY INCLUDED: UNKNOWN. ON (B)(6) 2025, AFTER THERMACARE NECK SHOULDER WRIST 12-HOUR INITIATION, THE PATIENT EXPERIENCED THERMAL BURN AND BLISTER. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2026 AND (B)(6) 2026 FROM THE REPORTING PHARMACY. THE CASE INVOLVES A FEMALE CUSTOMER IN HER LATE THIRTIES WHO APPLIED TWO NECK PLASTERS SIDE BY SIDE (ON THE NECK AND RIGHT SHOULDER) ON (B)(6) 2025. THE PLASTERS WERE PLACED DIRECTLY ON THE SKIN UNDER HER CLOTHING AND WORN FOR OVER 8 HOURS WHILE SHE WAS WORKING IN A SUPERMARKET. ALTHOUGH THE CUSTOMER ONLY FELT A "PLEASANT WARMTH" DURING USE, SHE DISCOVERED S

  Patient problems: Blister; Superficial (First Degree) Burn

  MAUDE report 24202015 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  (B)(6) PROVIDED THIS SPONTANEOUS REPORT TO BRIDGES CONSUMER HEALTHCARE ON 15-JAN-2026. (B)(6) RECEIVED THE REPORT ON 02-JAN-2026. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 02/JAN/2026 FROM A PHARMACIST THROUGH (B)(4). THE REPORT VERBATIM IS AS FOLLOWS: THIS CASE REPORT CONCERNS A FEMALE PATIENT (APPROXIMATELY 40 YEARS OLD), WHO APPLIED THERMACARE NECK SHOULDER WRIST 12 HOURS (LOT NUMBER: UNKNOWN, EXPIRATION DATE: UNKNOWN), USED FOR UNKNOWN INDICATION. CONCOMITANT MEDICATION(S): UNKNOWN. MEDICAL HISTORY INCLUDED: UNKNOWN. ON (B)(6) 2025, AFTER THERMACARE NECK SHOULDER WRIST 12-HOUR INITIATION, THE PATIENT EXPERIENCED THERMAL BURN AND BLISTER. FOLLOW-UP INFORMATION WAS RECEIVED ON 07-JAN-2026 AND 08-JAN-2026 FROM THE REPORTING PHARMACY. THE CASE INVOLVES A FEMALE CUSTOMER IN HER LATE THIRTIES WHO APPLIED TWO NECK PLASTERS SIDE BY SIDE (ON THE NECK AND RIGHT SHOULDER) ON (B)(6) 2025. THE PLASTERS WERE PLACED DIRECTLY ON THE SKIN UNDER HER CLOTHING AND WORN FOR OVER 8 HOURS WHILE SHE WAS WORKING IN A SUPERMARKET. ALTHOUGH THE CUSTOMER ONLY FELT A "PLEASANT WARMTH" DURING USE, SHE DISCOVERED SEVERE BURNS AND OPEN BLIS

  Patient problems: Blister; Superficial (First Degree) Burn

  MAUDE report 24201987 ↗
• InjuryJan 23, 2026Insufficient Device Problem Information

  ON 29-DEC-2025, A SPONTANEOUS REPORT WAS RECEIVED VIA EMAIL REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) IN ASSOCIATION WITH A THERMACARE MENSTRUAL HEAT WRAP. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED A THERMACARE MENSTRUAL HEAT WRAP AS DIRECTED WORN ON THE INSIDE OF HER UNDERWEAR FOR AN UNSPECIFIED INDICATION. LESS THAN 8 HOURS AFTER APPLYING THE PRODUCT, THE CONSUMER EXPERIENCED MULTIPLE SMALL BURNS ON HER SKIN WHICH WERE PAINFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s); Pain

  MAUDE report 24167435 ↗