ThermaCare HeatWraps ThermaCare HeatWraps - Lower Back & Hip (UDI 00305733010969)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00305733010969), received between Apr 9, 2019 and Apr 27, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2021Adverse Event Without Identified Device or Use Problem; Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating

  ON 01-APR-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6) FEMALE (ETHNICITY WAS NOT SPECIFIED) WHO WAS USING THE THERMACARE LOWER BACK AND HIP 8HR L/XL 2CT. MEDICAL HISTORY INCLUDED HYPERTENSION. THE CONSUMER HAD NO KNOWN DRUG ALLERGIES. CONCOMITANT PRODUCTS INCLUDED COZAAR (LOSARTAN POTASSIUM). PROVISION OF FURTHER MEDICAL HISTORY OR CONCOMITANT PRODUCT INFORMATION WAS DECLINED. THE CONSUMER HAD USED THE PRODUCT FOR SEVERAL YEARS. ON (B)(6) 2021, THE CONSUMER APPLIED ONE THERMACARE LOWER BACK AND HIP 8HR L/XL PATCH TOPICALLY AND IT BECAME TOO HOT FOR HER. SHE HAD TO REMOVE THE PATCH APPROXIMATELY AFTER AN HOUR. ON (B)(6) 2021, SHE APPLIED ANOTHER PATCH FROM THE SAME BOX AND SHE EXPERIENCED THE SAME ISSUE. SHE HAS NOT APPLIED ANOTHER PATCH SINCE. THE CONSUMER HAD DISCARDED THE PRODUCT AND THE PACKAGING AND WAS UNABLE TO PROVIDE THE LOT NUMBER AND EXPIRATION DATE. AS OF (B)(6) 2021, NO ADDITIONAL INFORMATION WAS PROVIDED. MULTIPLE FOLLOW UP ATTEMPTS HAD BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information; Partial thickness (Second Degree) Burn

  MAUDE report 11732510 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem

  EVENT VERBATIM [PREFERRED TERM] VERY LOW BLOOD SUGAR AFTER USING PRODUCT FOR AN HOUR [BLOOD GLUCOSE DECREASED] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR HIMSELF. A 70-YEAR-OLD MALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT NUMBER T98297, EXPIRATION DATE JAN2021, UDI NUMBER: (B)(4), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM 25FEB2019 USED THE PRODUCT FOR 1-2 HOURS FOR LOWER BACK PAIN. MEDICAL HISTORY INCLUDED ONGOING LOWER BACK PAIN. CONCOMITANT MEDICATION INCLUDED TRAMADOL 0.5MG TABLET FROM ABOUT 3 YEARS BEFORE (2016) ORALLY AT 0.5MG TWICE DAILY FOR LOWER BACK PAIN. THE PATIENT STATED HE TRIED THE HEAT WRAP ON (B)(6) 2019 AND WAS WONDERING IF THERE WERE ANY REPORTS OF A DIABETIC PATIENT HAVING A VERY LOW BLOOD SUGAR READING AFTER WEARING THE PRODUCT FOR AN HOUR. HE VERIFIED THAT THIS HAPPENED TO HIM ON (B)(6) 2019. A SAMPLE OF THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. THE ACTION TAKEN FOR THE PRODUCT AND EVENT OUTCOME WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY GROUP: INVESTIGATION SUMMARY: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). AF

  Patient problems: Hypoglycemia

  MAUDE report 9261098 ↗
• InjuryOct 31, 2019Moisture Damage

  HANDS TINGLY [PARAESTHESIA], SHE HAD OPENED TWO OF THE THREE WRAPS FROM THE LAST BOX AND THEY WERE BOTH WET [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A (B)(6)-YEAR-OLD FEMALE PATIENT STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) 8 HOUR, DEVICE LOT NUMBER Q01103, EXPIRATION DATE JUL2019, UDI NUMBER: (B)(4), SAP/UNIQUE IDENTIFIER: (B)(4), FROM 23JAN2017 AT AN UNKNOWN FREQUENCY FOR PAINFUL SPOT IN RIGHT HIP AND LOW BACK PAIN. MEDICAL HISTORY INCLUDED HYSTERECTOMY IN 2015, CHOLESTEROL AND ESTROGEN ABNORMAL AFTER HYSTERECTOMY. CONCOMITANT MEDICATION INCLUDED SIMVASTATIN FOR CHOLESTEROL ORALLY AT 40 MG ONCE A DAY FROM (B)(6) 2015 AND ONGOING AND ESTRADIOL ORALLY AT 2 MG ONCE A DAY FROM (B)(6) 2015 AND ONGOING FOR ESTROGEN AFTER HYSTERECTOMY. THE PATIENT REPORTED THAT INSIDE TWO INDIVIDUALLY PACKAGED THERMACARE LOWER BACK AND HIP HEAT WRAPS IT WAS WET. SHE HAD PURCHASED A PACKAGE OF THREE BOXES OF THE THERMACARE PRODUCT, WITH EACH BOX HAVING THREE INDIVIDUALLY WRAPPED HEAT WRAPS. SHE USED THE HEAT WRAPS FROM THE FIRST TWO BOXES AND THEY WERE FINE AND NOT WET. SHE HAD OPENED TWO OF THE THREE WRAPS FROM THE

  Patient problems: Tingling

  MAUDE report 9259574 ↗
• MalfunctionApr 9, 2019Leak/Splash; Loose or Intermittent Connection; Temperature Problem

  EVENT VERBATIM [PREFERRED TERM] CONTENTS ARE LEAKING OUT OF THE BOX/ WERE DRIPPING BLACK THINGS/ BLACK DOTS DRIPPING FROM THEM [DEVICE LEAKAGE] , . CASE NARRATIVE:THE INITIAL CASE WAS MISSING THE FOLLOWING MINIMUM CRITERIA: NO ADVERSE EVENT. UPON RECEIPT OF FOLLOW-UP INFORMATION ON 12MAR2019, THIS CASE NOW CONTAINS ALL REQUIRED INFORMATION TO BE CONSIDERED VALID. THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A 63-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), DEVICE LOT #1: T98297, EXPIRATION DATE: JAN2021; DEVICE LOT #2: 8071RA; EXPIRATION DATE: OCT2020 (AS REPORTED) FROM AN UNSPECIFIED DATE AT 1 PER DAY, FOR BACK INJURY. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT REPORTED "I RELY ON THERMACARE FOR DAILY USE OF THE HEATWRAPS. I HAVE 3 BOXES OF THERMACARE HEATWRAPS L-T98297 WITH BLACK STUFF COMING OUT OF THE HEATWRAPS. THE CONTENTS ARE LEAKING OUT OF THE BOX, IT WAS DRIPPING BLACK THINGS/ BLACK DOTS. I ALSO HAVE 3 BOXES OF THERMACARE HEATWRAPS THEY ONLY HEATED A PERCENTAGE OF THE TIME 3 TO 4 HOURS." ON AN UNSPECIFIED DATE, THE PATIENT ALSO REPOR

  Patient problems: No Information

  MAUDE report 8495597 ↗