ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & Hip (UDI 00305733010389)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00305733010389), received between May 12, 2022 and May 19, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  ON 27-APR-2022, A SPONTANEOUS REPORT WAS RECEIVED FROM THE UNITED STATES VIA EMAIL FROM A CONSUMER REGARDING A MALE CONSUMER (AGE NOT PROVIDED) WHO USED THERMACARE LOWER BACK AND HIP L/XL HEAT WRAPS. MEDICAL HISTORY INCLUDED ARTHRITIS IN THE KNEES AND PRIOR USE OF THERMACARE LOWER BACK AND HIP HEAT WRAPS WITHOUT ISSUES. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER PURCHASED A PACKAGE OF THERMACARE LOWER BACK AND HIP HEAT WRAPS. ON AN UNSPECIFIED DATE, AFTER THE CONSUMER OPENED THE PACKAGE, HE DISCOVERED THAT 6 TO 7 WRAPS WERE DAMAGED. IT APPEARED THAT THE WRAPS WERE CUT INCORRECTLY WHICH EXPOSED THE HEATING MATERIAL TO THE AIR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14434962 ↗
• InjuryMay 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA EMAIL REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) WHO USED A THERMACARE LOWER BACK AND HIP HEAT WRAP. MEDICAL HISTORY INCLUDED USE OF THERMACARE HEAT WRAPS USED AS NEEDED FOR YEARS WITHOUT ISSUE. CONCOMITANT PRODUCTS INCLUDED TRAZODONE, BUPROPION, AND DULOXETINE. ON APPROXIMATELY (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP HEAT WRAP FOR AN UNSPECIFIED INDICATION ON HER BACK OVER A HIGH WASTED UNDERWEAR. ON (B)(6) 2022, AFTER 8 HOURS OF APPLYING THE HEAT WRAP WHEN THE CONSUMER TOOK THE HEAT WRAP OFF BEFORE SHE WENT TO BED. SHE NOTICED THAT HER BACK WAS BURNED. IT WAS CLARIFIED THAT HER HUSBAND SAW A DARK AREA ON HER LOWER BACK IN SHAPE OF THE PRODUCT. THE AREA WAS DARKER IN THE AREAS WHERE THE COIL WOULD HAVE BEEN. SHE SAID IT WAS NOT RED OR A BURN INITIALLY, AND THE FIRST WEEK THE AREA WAS UNCOMFORTABLE. FOR TREATMENT SHE HAD BEEN APPLYING LOTION TO SOOTH HER SKIN. AS OF (B)(6) 2022, THE DARKNESS ON HER SKIN WAS FADING BUT IT HAD NOT RETURN TO NORMAL. NO FURTHER DEVICE INFORMATION WAS PROVIDED AS IT WAS DISCARDED.

  Patient problems: Burn(s); Pain; Skin Discoloration

  MAUDE report 14375430 ↗