ThermaCare HeatWraps ThermaCare HeatWraps - Muscle & Joint (UDI 00305733013038)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00305733013038), received between Jan 24, 2019 and Sep 29, 2022 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 10-SEP-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) WHO USED THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE NECK/SHOULDER/WRIST 8HR HEAT WRAP. ON AN UNSPECIFIED DATE IN (B)(6) 2022, WHILE WEARING THE HEAT WRAP THE CONSUMER WORKED IN THE HEAT AND EXPERIENCED A BURN. FOLLOW UP ATTEMPTS HAVE NOT BEEN SUCCESSFUL IN OBTAINING ADDITIONAL INFORMATION.

  Patient problems: Burn(s)

  MAUDE report 15503058 ↗
• MalfunctionApr 1, 2022Insufficient Heating; Insufficient Heating

  ON 16-MAR-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA EMAIL REGARDING A FEMALE CONSUMER (AGE NOT REPORTED) WHO WAS USING THERMACARE MENSTRUAL 8HR 3CT. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER NOTED THAT ALL THREE HEAT WRAPS IN THE BOX WERE NOT WORKING. THE CONSUMER STATED, "THE LITTLE POCKETS LOOK AND FEEL LIKE THEY ARE FILLED SO FULL THEY ARE ABOUT TO BURST OPEN AND ARE HARD AS A ROCK." A FOLLOW UP EMAIL WAS SENT TO THE CONSUMER ON 18-MAR-2022. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13982822 ↗
• MalfunctionDec 30, 2021Packaging Problem; Packaging Problem

  ON 03-DEC-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A FEMALE (AGE NOT REPORTED) WHO ATTEMPTED TO USE THERMACARE HEATWRAPS MUSCLE PAIN THERAPY. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED.ON AN UNSPECIFIED DATE, THE CONSUMER OPENED A PACKAGE OF THERMACARE HEATWRAPS MUSCLE PAIN THERAPY (LOT NUMBER GA0022: EXPIRATION DATE NOT PROVIDED). ON AN UNSPECIFIED DATE, AFTER OPENING A PACKAGE OF THERMACARE HEATWRAPS MUSCLE PAIN THERAPY, THE CONSUMER NOTED THAT THE ONE OF THE HEAT WRAPS CAME APART. IT WAS CLARIFIED THAT THE HEATING ELEMENT OPENED UP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13121847 ↗
• InjuryOct 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 14-SEP-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A CONSUMER REGARDING A FEMALE CONSUMER WHO WAS USING A THERMACARE MENSTRUAL 8HR HEAT WRAP. MEDICAL HISTORY INCLUDED MENSTRUAL PAIN. ADDITIONAL MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED A THERMACARE MENSTRUAL 8HR HEAT WRAP FOR MENSTRUAL PAIN. AFTER THE CONSUMER WORE A THERMACARE MENSTRUAL 8HR HEAT WRAP FOR 8 HOURS WHILE WORKING, THE CONSUMER NOTED THAT THE SHE HAD A BLISTER, "LIKE THE FIRST LAYER OF SKIN WAS GONE." FOLLOW UP ATTEMPTS HAVE BEEN ATTEMPTED AND UNSUCCESFUL IN OBTAINING ADDITIONAL INFORMATION.

  Patient problems: Blister; Peeling

  MAUDE report 12570335 ↗
• InjurySep 22, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 24-AUG-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A CONSUMER REGARDING A (B)(6) FEMALE CONSUMER WHO WAS USING A THERMACARE MENSTRUAL 8HR HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCT USE WERE NOT PROVIDED. ON (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED A THERMACARE MENSTRUAL 8HR HEAT WRAP (LOT NUMBER AND EXPIRATION DATE WERE UNKNOWN) TO HER LOWER ABDOMEN AREA FOR 5 TO 6 HOURS. THE NEXT EVENING ((B)(6) 2021) SHE APPLIED A THERMACARE MENSTRUAL 8HR HEAT WRAP TO HER LOWER ABDOMEN FOR AN ADDITIONAL 5-6 HOURS. ON (B)(6) 2021, THE CONSUMER EXPERIENCED ITCHING, SKIN IRRITATION, AND PAIN TO THE APPLICATION SITE AREA. AT ONE POINT SHE SCRATCHED THE AREA WHICH CAUSED IT TO BLEED. THE AREA WAS A LITTLE BIGGER THAN A PINHEAD. THE BLEEDING WAS CONTROLLED IMMEDIATELY. FOR TREATMENT, SHE USED ALOE AND SOLARCAIN ON THE AREA WHICH PROVIDED LITTLE RELIEF. THE CONSUMER DID NOT HAVE THE PACKAGING OR ANY FURTHER MEDICAL DEVICE SPECIFIC IDENTIFYING INFORMATION. AS OF (B)(6) 2021, THE CONSUMER'S SCRATCH WAS HEALED, AND HER SYMPTOMS WERE A LITTLE BETTER BUT HAD NOT FULLY RESOLVED. ON 31-AUG-2021, ADDITIONAL INFORMATION WAS PROVIDED BY A CONSUMER. MEDICAL HISTO

  Patient problems: Burn(s); Erythema; Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation; Skin Tears; Urticaria

  MAUDE report 12512399 ↗
• InjuryMay 21, 2021Excessive Heating; Excessive Heating

  ON 23-APR-2021, A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA A PHARMACEUTICAL COMPANY (REFERENCE NUMBER: 13927808) REGARDING A FEMALE CONSUMER (AGE NOT REPORTED) WHO USED THE THERMACARE MENSTRUAL 8HR 3CT HEAT WRAP (LOT NUMBER: 496668, EXPIRATION DATE: 13-MAY-2022). MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, ON OR BEFORE 13-FEB-2021, THE CONSUMER TOPICALLY APPLIED THE THERMACARE MENSTRUAL 8HR 3CT HEAT WRAP FOR AN UNSPECIFIED INDICATION TO HER STOMACH. ON AN UNSPECIFIED DATE AFTER APPLYING THE PRODUCT, THE CONSUMER EXPERIENCED FEELING THAT THE PRODUCT BURNS EXTREMELY BAD. WHEN THE PRODUCT WAS PULLED OFF IT PEELED HER SKIN OFF. IT WAS FURTHER CLARIFIED AS, IT TOOK A LAYER OF HER SKIN OFF. NO ADDITIONAL INFORMATION WAS PROVIDED. MULTIPLE FOLLOW UP ATTEMPTS WERE INITIATED BUT WERE UNSUCCESSFUL.

  Patient problems: Burning Sensation; Skin Tears

  MAUDE report 11862989 ↗
• InjuryOct 31, 2019Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT VERBATIM [PREFERRED TERM] BLISTERS [BLISTER]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A 76-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN), DEVICE LOT NUMBER T26686, EXPIRATION DATE JUL2020, UDI NUMBER: (B)(4), SINCE AN UNSPECIFIED DATE (TOO MANY YEARS AGO, IT HAD BEEN 5 OR 6 YEARS AGO) AT UNKNOWN FREQUENCY FOR MUSCLE PAIN, SHOULDER PAIN, AND ELBOW PAIN. MEDICAL HISTORY INCLUDED TORN ROTATOR CUFF FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING AND SHRUNK TWO AND A HALF INCHES (WHEN THE PATIENT WAS 30 YEARS OLD SHE WAS 5 FOOT 11 AND NOW SHE WAS 76 AND SHE WAS 5 FOOT SEVEN AND A HALF). THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT STATED, SHE HAD A BOX OF THE THERMACARE SHE GOT A LETTER FROM THE (CLUB NAME) WHERE SHE BOUGHT IT, IT WAS ON A RECALL. THE PATIENT MENTIONED NO DOCTOR PRESCRIBED IT TO HER. SHE USED IT ((THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN) BEFORE UNTIL SHE GOT TO A DOCTOR. THE PATIENT STATED, SHE HAD A TORN ROTATOR CUFF, SHE HAD ELBOW THAT NEEDED TO BE REPLACE IT WAS BONE ON BONE, SHE HAD PAIN. THAT WAS WHY SHE USED THESE (THERMACARE HEATWRAPS MULTI-PURP

  Patient problems: Swelling

  MAUDE report 9260669 ↗
• InjuryMar 28, 2019Therapeutic or Diagnostic Output Failure; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TAPE DOESN'T STAY ON THE WRAPS/DOES NOT STICK TO SKIN FALLS OFF [DEVICE ADHESION ISSUE]. THEY DON'T WORK, THEY EXPIRED IN AUG 2017 [DEVICE INEFFECTIVE]. THEY DON'T WORK, THEY EXPIRED IN AUG 2017 [EXPIRED DEVICE USED]. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTED FOR HIMSELF. A 71-YEAR-OLD MALE PATIENT STARTED TO USE THERMACARE HEATWRAP (THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN) (DEVICE LOT NUMBER: X70537, EXPIRY DATE: AUG2017, UDI NUMBER (B)(4), LOT NUMBER: X70537, EXPIRY DATE: JUL2021) FROM AN UNKNOWN DATE AT UNKNOWN FREQUENCY FOR PAIN IN RIGHT SHOULDER. MEDICAL HISTORY WAS NOT REPORTED. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT BOUGHT THERMACARE ADVANCED MUSCLE PAIN THERAPY ON 06FEB2019, AND IN (B)(6) 2019 THEY DIDN'T WORK, THEY EXPIRED IN AUG2017. THE STUFF THAT HELD IT ON THE ENDS, THE TAPE DIDN'T STAY ON IN (B)(6) 2019. THE PATIENT FURTHER REPORTED DID NOT STICK TO SKIN, FELL OFF. THE PATIENT WAS ADMITTED TO HOSPITAL FOR EVENT TAPE DOESN'T STAY ON THE WRAPS. HE WAS NOT ADMITTED TO HOSPITAL FOR OTHER EVENTS. NO TREATMENT RECEIVED FOR ANY EVENTS. DEVICE WAS AVAILABLE FOR EVALUATION. ACTION TAKEN IN RESPONSE TO THE EVENTS OF T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8459997 ↗
• InjuryMar 21, 2019Patient-Device Incompatibility; Physical Resistance/Sticking

  EVENT VERBATIM [PREFERRED TERM] SHE WAS BLEEDING [HAEMORRHAGE] , RIPPED HIS MOM'S SKINS RIGHT OFF [SKIN EXFOLIATION] , SHOWERING HURT THE AREA ON HIS MOTHER AND MADE IT MORE PAINFUL [PAIN] , THE ADHESIVE IS WAY TOO STRONG [DEVICE ADHESION ISSUE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HIS MOTHER. A 60-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MUSCLE & JOINT), DEVICE LOT NUMBER W24915, EXPIRATION DATE MAR2021, UPC NUMBER: 305733013038, FROM AN UNSPECIFIED DATE AT 1 HEATWRAP APPLIED TO HER SHOULDER AREA IN THE BACK FOR SHOULDER PAIN. THERE WERE NO MEDICAL HISTORY AND CONCOMITANT MEDICATIONS. THE CONSUMER REPORTED THAT HE AND HIS MOTHER HAVE BEEN USING THE PRODUCT FOR YEARS. HE REPORTED THAT THE ADHESIVE WAS WAY TOO STRONG AND SAID THAT IT RIPPED HIS MOM'S SKIN RIGHT OFF AND SHE WAS BLEEDING ON (B)(6) 2018. HE SAID THAT HE HAD PICTURES OF THE SITE. HE REPORTED THAT SHOWERING HURT THE AREA ON HIS MOTHER AND MADE IT MORE PAINFUL. SHE WAS TREATING THE AFFECTED AREA BY KEEPING IT CLEAN AND USING NEOSPORIN. NO LAB DATA WAS PROVIDED. THE CONSUMER REPORTED SERIOUSNESS CRITERIA AS MALFUNCTION. THE GLUE WAS WAY

  Patient problems: Abrasion; Blood Loss; Pain

  MAUDE report 8440960 ↗
• MalfunctionJan 24, 2019Break; Fluid/Blood Leak; Nonstandard Device

  EVENT VERBATIM [PREFERRED TERM] I THREW THE PACKAGE AWAY BECAUSE THEY WERE LEAKING [DEVICE LEAKAGE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. THIS MALE CONSUMER OF UNKNOWN AGE REPORTED FOR THERMACARE HEATWRAP (THERMACARE MENSTRUAL) LOT NUMBER T26691, EXPIRATION DATE JUL2020. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. CONSUMER WANTED REIMBURSEMENT ON THE HEATWRAPS THAT'S ON RECALL. HE BOUGHT 2 MENSTRUAL PAIN THERAPY 8HR AND 1 MUSCLE PAIN THERAPY 8HR. UPC (B)(4). HE THREW THE PACKAGE AWAY BECAUSE THEY WERE LEAKING. THEY WERE THE ONES ON RECALL. THE ACTION TAKEN IN RESPONSE TO THE EVENT OF THE PRODUCT WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). THE RETURN SAMPLE IS NOT AVAILABLE FROM CONSUMER FOR EVALUATION THE COMPLAINT CANNOT BE CONFIRMED. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA OR, INSPECTIO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273594 ↗