ThermaCare HeatWraps ThermaCare HeatWraps - Muscle & Joint (UDI 00305733013014)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00305733013014), received between May 6, 2020 and May 6, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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.

• InjuryMay 6, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  RED CIRCLES ON HER KNEE THAT WERE NOT REALLY BLISTERS, WHERE THE CIRCLES IN THE WRAP WERE LOCATED [RASH MACULAR], THEY LOOKED LIKE LITTLE CIRCLES WHERE THE CIRCLES WERE IN THE PATCH [DEVICE ISSUE], NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A (B)(6) FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN), UDI#: (B)(4), ON (B)(6) 2020 AT 1 WRAP APPLIED TOPICALLY TO THE RIGHT KNEE FOR ABOUT 1 HOUR FOR HER KNEE WAS BOTHERING HER. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NONE. THE PATIENT STATED THAT SHE WAS CALLING ABOUT THERMACARE HEATWRAPS, SHE USED ONE YESTERDAY ON (B)(6) 2020, SHE HAD IT ON HER KNEE AND TOOK IT OFF ABOUT AN HOUR LATER AND SHE GOT THESE SPOTS THAT LOOKED LIKE LITTLE BLISTERS. SHE WAS WONDERING WHY THE PRODUCT DID THIS? THE PATIENT STATED THAT SHE HAD 4 MORE OF THE WRAPS THAT HAD NEVER BEEN OPENED, SHE WAS A LITTLE SCARED TO USE THEM. SHE CLARIFIED THAT THEY WERE NOT REALLY BLISTERS, THEY LOOKED LIKE LITTLE CIRCLES WHERE THE CIRCLES WERE IN THE PATCH. SHE STATED SHE HAD RED CIRCLES ON HER KNEE THAT WERE NOT REALLY BLISTERS, WHERE THE CIRCLES IN THE WRAP WERE LOCATED. SHE STATE

  Patient problems: Erythema; Pain; Swelling

  MAUDE report 10031028 ↗