ThermaCare HeatWraps ThermaCare HeatWraps - Flexible (UDI 00305733017258)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00305733017258), received between Jan 28, 2021 and Jan 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionJan 28, 2021Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  EVENT VERBATIM [PREFERRED TERM] LEAKAGE IN A HEATWRAP FROM A BOX [DEVICE LEAKAGE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO USE THERMACARE HEATWRAP (THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN) (DEVICE LOT NUMBER EC2278, EXPIRATION DATE JUN2023, UPC NUMBER: 305733017258) FROM AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT REPORTED LEAKAGE IN A HEATWRAP FROM A BOX OF ADVANCED JOINT PAIN THERAPY WRAPS. THE PATIENT DIDN'T KNOW WHETHER IT WAS SAFE TO USE THE REMAINING WRAPS. THE SAMPLE WAS AVAILABLE TO BE RETURNED FOR EVALUATION. ACTION TAKEN IN RESPONSE TO THE EVENT WAS UNKNOWN. THE CLINICAL OUTCOME OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT (PQC) GROUP INCLUDED INVESTIGATION RESULTS. THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THE RETURN SAMPLE EVALUATION SHOWS NO CELL DAMAGE OR LEAKS PRESENT ON THE WRAPS. THE CELL PACKS ARE INTACT; NO CHEMISTRY IS LEAKING FROM THE CELLS. NO FURTHER ACTION IS REQUIRED. OUR MANUFACTURING O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11245950 ↗