ThermaCare HeatWraps ThermaCare HeatWraps - Muscle & Joint (UDI 00305733013144)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00305733013144), received between Apr 21, 2021 and Apr 21, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Excessive Heating” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2021Excessive Heating; Excessive Heating

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6) FEMALE (ETHNICITY WAS NOT SPECIFIED) WHO WAS USING THE THERMACARE MUSCLE/JOINT 8HR 3 +1 CT(LOT NUMBER: LCJ8289NO6/02; EXPIRATION DATE MAY-2020). THE CONSUMER DECLINED TO PROVIDE MEDICAL HISTORY AND INFORMATION ABOUT USAGE OF ANY CONCOMITANT PRODUCTS. THE CONSUMER HAD USED THE PRODUCT FOR MANY YEARS WITHOUT ISSUE. ON (B)(6) 2021, THE CONSUMER APPLIED ONE THERMACARE MUSCLE/JOINT HEAT WRAP TOPICALLY TO HER LOWER BACK AND THEN SHE WENT TO SLEEP. SIX HOURS LATER, THE CONSUMER WOKE UP TO A BURNING SENSATION. SHE IMMEDIATELY REMOVED THE PRODUCT. WHEN SHE REMOVED THE PRODUCT, SHE RIPPED OFF SOME SKIN. SHE THOUGHT THE PAIN WAS DUE TO THE FACT THAT THE PATCH HAD TOO MUCH ADHESIVE. HOWEVER, SHE HAD HER MOTHER (WHO IS A BURN NURSE) LOOK AT THE AREA AND SHE STATED THERE WAS A BURN AT THE APPLICATION SITE. INITIALLY, NO TREATMENT WAS PERFORMED EXCEPT SHE PUT A LOOSE FITTING SHIRT. ON (B)(6) 2021, THE APPLICATION SITE AREA WAS PAINFUL AND A BLISTER HAD BROKEN OPEN. ON (B)(6) 2021, THE CONSUMER WENT TO AN EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH A SECOND DEGREE BURN. FOR TREATMENT SHE WAS

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

  MAUDE report 11703146 ↗