ThermaCare HeatWraps ThermaCare HeatWraps - Neck, Wrist & Shoulder (UDI 00305733015445)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00305733015445), received between Apr 9, 2019 and Apr 9, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (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 9, 2019Peeled/Delaminated; Device Slipped

  EVENT VERBATIM [PREFERRED TERM] SHE TAKES HER PANTS UP AND DOWN IT'S PEELING OFF AND AGAIN [DEVICE ADHESION ISSUE] , SHE IS USING THE WRAPS ON HER BACK/SHE DOESN'T PRESS ON IT SHE DOESN'T FEEL THE HEAT/SHE HAS TO PRESS ON [DEVICE USE ISSUE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTED FOR HERSELF. A 73-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST), LOT NUMBER: T65610, EXPIRY DATE: SEP2020, UPC NUMBER: 305733015445, FROM AN UNSPECIFIED DATE AT 1 PK TWICE A DAY FOR PAIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT SAID SHE HAD THE THERMACARE HEAT WRAPS FOR THE NECK, WRIST AND SHOULDER BUT SHE WAS USING THE WRAPS ON HER BACK AND NECK IN SEP2017. SHE SAID THE WRAPS WERE WORKING BEAUTIFULLY ON HER BACK. SHE THOUGHT THAT WAS WHAT SHE BOUGHT. THE THERMACARE NECK, WRIST AND SHOULDER ON HER NECK DIDN'T STICK. THE TAPE KEPT OPENING. SHE ALSO HAD A BOX SHE HAD NOT OPENED YET. SHE SAID SHE WOULD NEED THE THERMACARE HEAT WRAPS FOR THE NECK, WRIST AND SHOULDER. SHE THEN STATED THAT WHAT SHE HAD WAS THERMACARE FOR THE NECK AND SHE HAD TWO BOXES. SHE ASKED IF SHE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495592 ↗