ThermaCare HeatWraps ThermaCare HeatWraps - Menstrual (UDI 00305733020449)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00305733020449), received between Nov 2, 2018 and Apr 15, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 05-APR-2022 A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A (B)(6) FEMALE CONSUMER WHO USED A THERMACARE MUSCLE/JOINT 8HR HEAT WRAP. MEDICAL HISTORY INCLUDED HIGH BLOOD PRESSURE, ASTHMA, AND A BURN BLISTER FROM A CURLING WAND (RESOLVED). ALLERGIES INCLUDED FLAGYL (METRONIDAZOLE), LOSARTAN, LISINOPRIL, AND SULFONAMIDES. CONCOMITANT PRODUCTS INCLUDED AN UNSPECIFIED BLOOD PRESSURE MEDICATION AND AN UNSPECIFIED INHALER. ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE MUSCLE/JOINT 8HR HEAT WRAP ON HER UPPER BACK ON THE RIGHT SIDE OF HER RIB CAGE DIRECTLY TO HER SKIN. ON (B)(6) 2022, AN UNSPECIFIED TIME-PERIOD AFTER APPLICATION OF THE HEAT WRAP (CLARIFIED AS "NOT VERY LONG AND DEFINITELY LESS THAN 8 HOURS"), THE CONSUMER EXPERIENCED THE PRODUCT DID NOT ADHERE WELL TO HER SKIN. SHE COULD FEEL HEAT FROM THE HEAT WRAP AFTER APPLICATION WHICH WAS NOT PAINFUL. UPON PRODUCT REMOVAL, SHE NOTED THAT SHE HAD 3 BLISTERS AT THE APPLICATION AREA. THE BLISTERS WERE SMALLER THAN A QUARTER AND WERE STILL INTACT. SHE DID NOT PERFORM ANY HOME TREATMENTS AND DID NOT SEE A MEDICAL PROVIDER. THE CONSUMER DENIED THE NEED FOR MEDICAL EVALUATION

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 14120533 ↗
• MalfunctionOct 31, 2019Unintended Ejection; Leak/Splash; Nonstandard Device; Leak/Splash

  EVENT VERBATIM [PREFERRED TERM]. THEY ALSO WENT THROUGH HER PANTS AND UNDERWEAR, MAKING CONTACT WITH HER SKIN/THE WRAP WAS LEAKING [ACCIDENTAL EXPOSURE TO PRODUCT], BLACK DOTS LEAKED ON THE FLOOR, IN THE SEAT, ON THE BED, THROUGH HER PANTS AND UNDERWEAR MAKING CONTACT WITH CALLERS SKIN/SAND WAS LEAKING FROM WRAP/THE WRAP WAS LEAKING [DEVICE LEAKAGE], NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HERSELF. A 34-YEAR-OLD FEMALE PATIENT STARTED TO USE THERMACARE HEATWRAP (THERMACARE MENSTRUAL), DEVICE LOT NUMBER T26693, EXPIRATION DATE AUG2020, UNIQUE IDENTIFIER (B)(4), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM (B)(6) 2018 AT 1 A DAY, 6 HOURS FOR CRAMPS/PELVIC CRAMPS AND CHRONIC PELVIC PAIN. THERE WERE NO CONCOMITANT MEDICATIONS, OTHER MEDICAL CONDITIONS OR RELEVANT INVESTIGATIONS. THE PATIENT HAD USED THERMACARE HEATWRAP (THERMACARE MENSTRUAL) WRAPS FOR 10-15 YEARS WITHOUT ANY ISSUES. SHE USED 3 BOXES A MONTH FOR CHRONIC PELVIC PAIN. SHE WATCHED A 2 YEAR OLD. SHE PURCHASED THE WRAPS ABOUT A WEEK BEFORE ((B)(6) 2018). THE BOX AND THE PACKAGES WERE PROPERLY SEALED. SHE OPENED THE WRAP, REMOVED THE PAPER AND APPLIED THE STICKY PART AGAINST HER UN

  Patient problems: Chemical Exposure

  MAUDE report 9259946 ↗
• MalfunctionOct 30, 2019Unintended Ejection

  EVENT VERBATIM [PREFERRED TERM] IT WAS AGAINST THE SKIN IN MORE THAN ONE PLACE [ACCIDENTAL EXPOSURE TO PRODUCT] , THERE WAS CHARCOAL, OR WHATEVER THE BLACK SUBSTANCE IS, COMING OUT OF THE WRAP IN TWO DIFFERENT SPOTS. IT WAS AGAINST MY SKIN IN MORE THAN ONE PLACE [DEVICE LEAKAGE]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL), EXPIRATION DATE AUG2020, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE CONSUMER PUT ON THE PRODUCT ON (B)(6) 2018 AND THE NEXT TIME TO THE BATHROOM, THERE WAS CHARCOAL, OR WHATEVER THE BLACK SUBSTANCE WAS, COMING OUT OF THE WRAP IN TWO DIFFERENT SPOTS. IT WAS AGAINST THE SKIN IN MORE THAN ONE PLACE. "I DIDN'T HAVE IT ON THAT LONG", BUT LOST THE USE OF THE WRAP BECAUSE OF THE FAULTY SEAL. THE CONSUMER FURTHER REPORTED THAT REGARDING WRAP BREAKING OPEN. THE REPORTER HAD A SECOND ONE DID IT THE NEXT CYCLE. THE UPC CODE FOR THE BOX THEY CAME OUT OF WAS 3 0573 3020 44 9. THE EXPIRATION

  Patient problems: Chemical Exposure

  MAUDE report 9258460 ↗
• InjuryApr 26, 2019Insufficient Device Problem Information

  EVENT VERBATIM [PREFERRED TERM] HORRIBLE BURNS [BURNS SECOND DEGREE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL), LOT (L) S70434/EXPIRATION: MAR2020 LOT (L) S68523/ EXPIRATION: APR2020, ON (B)(6) 2018 FOR AN UNSPECIFIED INDICATION. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT REPORTED "I PUT IT ON MY TANK TOP AND THEN TUCK IN MY SHIRT AND IT ENDED UP IN THE CRAMPING AREA AND WHEN I WENT TO USE THE BATHROOM 4 HOURS LATER I HAD HORRIBLE BURNS" ON (B)(6) 2018. THE PATIENT FURTHER REPORTED "I DON'T KNOW HOW I GOT BURNS WHEN I DIDN'T BUNCH IT UP AND WASN'T ON MY SKIN AT ALL" THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP AND THE OUTCOME OF THE EVENT WAS UNKNOWN. THIS REPORT HAS BEEN ASSESSED AS SERIOUS AND REPORTABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT OF "BURNS SECOND DEGREE" AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVEN

  Patient problems: Cramp(s); Partial thickness (Second Degree) Burn

  MAUDE report 8558481 ↗
• MalfunctionApr 12, 2019Break; Leak/Splash; Nonstandard Device

  EVENT VERBATIM [PREFERRED TERM] GEL CELLS LEAKING [DEVICE LEAKAGE] , . CASE NARRATIVE:THE INITIAL CASE WAS MISSING THE FOLLOWING MINIMUM CRITERIA: NO ADVERSE EVENT, PRODUCT COMPLAINT ONLY. UPON RECEIPT OF FOLLOW-UP INFORMATION ON 24OCT2018, THIS CASE NOW CONTAINS ALL REQUIRED INFORMATION TO BE CONSIDERED VALID. THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER OR OTHER NON HCP. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO USE THERMACARE HEATWRAP (THERMACARE MENSTRUAL) (DEVICE LOT NUMBER T26693, EXPIRATION DATE AUG2020) FROM (B)(6) 2018 FOR DYSMENORRHOEA. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2018, THE PATIENT REPORTED SHE BOUGHT 2 BOXES AND ONE OF THE CELL COMPARTMENTS THAT HEAT UP WAS NOT SEALED AND THE GEL WAS COMING OUT. SHE STATED IT IS THE LITTLE GRAY THINGS THAT WERE LEAKING OUT ONTO THE CHARCOAL THING. THE PATIENT STATED THE FIRST AND SECOND WRAPS SHE OPENED WERE BAD, THE THIRD ONE WAS FINE. SHE WAS A MESS AFTER SHE OPENED THE FIRST ONE AND THREW IT AWAY. SHE STILL HAS THE SECOND BOX. ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. CLINICAL OUTCOME OF THE EVENT WAS UNKNOWN. ADDITIONAL INFO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8508631 ↗
• MalfunctionNov 2, 2018Break; Leak/Splash; Nonstandard Device

  EVENT VERBATIM [PREFERRED TERM] TWO OF THEM BROKE OPEN AND ALL THAT BLACK STUFF WITHIN THAT CAME OUT [DEVICE LEAKAGE] , . CASE NARRATIVE:THE INITIAL CASE WAS MISSING THE FOLLOWING MINIMUM CRITERIA: NO ADVERSE EFFECT. UPON RECEIPT OF FOLLOW-UP INFORMATION ON 18OCT2018, THIS CASE NOW CONTAINS ALL REQUIRED INFORMATION TO BE CONSIDERED VALID. THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A (B)(6)-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL), DEVICE LOT NUMBER T26693, EXPIRATION DATE AUG2020, NDC NUMBER: (B)(4), UPC NUMBER: (B)(4), FROM (B)(6) 2018 AT AN UNSPECIFIED FREQUENCY FOR MENSTRUAL. THERE WERE NO MEDICAL HISTORY AND CONCOMITANT MEDICATIONS. THE PATIENT REPORTED SHE WAS USING A THERMACARE HEATWRAP FOR THE MENSTRUAL ONE AND TWO OF THEM BROKE OPEN AND ALL THAT BLACK STUFF WITHIN THAT CAME OUT ON (B)(6) 2018. NO LAB WORK WAS DONE. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS UNKNOWN. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: THE ROOT CAUSE FOR THIS INVESTIGATION WAS REVISED PER INVESTIGATION (B)(4) T26691, T26693, T26686 & S68516 MENSTRUAL & MUSCLE JO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8032910 ↗