ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & Hip (UDI 00305733010075)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00305733010075), received between Oct 30, 2019 and Oct 30, 2019 — 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.

• MalfunctionOct 30, 2019Leak/Splash; Material Split, Cut or Torn

  EVENT VERBATIM [PREFERRED TERM] WRAP WAS SPLIT WITH CHARCOAL ALL OVER/ALL 3 HAD A SPLIT ON TOP [DEVICE LEAKAGE]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A 59-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER R67987, EXPIRATION DATE AUG2019, UDI NUMBER (B)(4), FROM AN UNSPECIFIED DATE AT UNKNOWN FREQUENCY FOR BACK ISSUES. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT HAD BACK ISSUES AND SHE HAD BEEN BUYING THESE WRAPS FOR ABOUT 5 YEARS. SHE BOUGHT A BOX WITH 2 PLUS 1 FREE WRAP. WHEN SHE OPENED THE BOX, THE WRAP WAS SPLIT WITH THE CHARCOAL ALL OVER. SHE CLARIFIED THERE WAS CHARCOAL IN THE POUCH THAT SHE FOUND WHEN SHE WENT TO PULL THE WRAP OUT. IT WAS SPLIT ACROSS THE TOP AND BLACK STUFF WAS EVERYWHERE. THE SECOND WRAP WAS THE SAME WAY. SHE DID NOT OPEN THE THIRD WRAP, BUT SHE SHOOK THE POUCH AND SHE COULD TELL IT WAS THE SAME WAY. DEVICE WAS AVAILABLE FOR EVALUATION. THE PATIENT HAD PURCHASED THERMACARE BONUS 3PK. ALL 3 HAD A SPLIT ON TOP. PROBABLY HAPPENED IN MANUFACTURING PROCESS. SHE DIDN'T USE THEM. SHE HAD BEEN USING THERMACARE HEATWRAPS FOR OV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9257599 ↗