ThermaCare HeatWraps ThermaCare HeatWraps - Neck, Wrist & Shoulder (UDI 00305733015353)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00305733015353), received between Apr 27, 2021 and Apr 27, 2021 — classified as 1 injury.

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 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM FRANCE RECEIVED ON (B)(6) 2021 FROM A PHARMACIST THROUGH COOPER ((B)(6)). THIS CASE REPORT CONCERNS A FEMALE PATIENT, AGED BETWEEN 35 AND 40 YEARS, WHO APPLIED THERMACARE HEAT WRAPS NECK SHOULDER WRIST FOR DRUG USE FOR UNKNOWN INDICATION. THE PATCH HAS BEEN APPLIED IN THE MORNING AND REMOVED IN THE EVENING. CONCOMITANT MEDICATION(S): NOT REPORTED. ON AN UNKNOWN DATE AFTER THERMACARE HEAT WRAPS NECK SHOULDER WRIST INITIATION, THE PATIENT DEVELOPED PURULENT BLISTERS. THE PATCH HAS BEEN APPLIED IN THE MORNING AND REMOVED IN THE EVENING. THE PATIENT DID NOT RECEIVE TREATMENT FOR THIS EVENT. RELEVANT LABORATORY TEST RESULTS WERE NOT REPORTED. OUTCOME: PURULENT BLISTERS : UNKNOWN. THE REPORTER ASSESSED THIS REPORT AS SERIOUS AND DIDN'T PROVIDE CAUSAL RELATIONSHIP TO THERMACARE HEAT WRAPS NECK SHOULDER WRIST.

  Patient problems: Blister

  MAUDE report 11733638 ↗