ThermaCare HeatWraps ThermaCare HeatWraps - Flexible (UDI 00305733017241)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00305733017241), received between Oct 29, 2018 and Sep 16, 2021 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON 20-AUG-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A (B)(6) FEMALE CONSUMER REGARDING THE THERMACARE JOINT THERAPY 8HR 4CT. MEDICAL HISTORY AND INFORMATION REGARDING USAGE OF CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON ABOUT (B)(6) 2021, THE CONSUMER OPENED TWO BOXES OF THERMACARE JOINT THERAPY 8HR 4CT (EXPIRATION DATES OF 11/2023 AND 04/2023). WHEN OPENING THE PRODUCTS, SHE DISCOVERED THAT APPROXIMATELY FOUR OF THEM DID NOT HEAT UP AND ALL WERE LEAKING BLACK FLUID FROM THEM. CONSUMER HAS RETAINED PRODUCT PACKAGING FOR POSSIBLE RETRIEVAL. ON 24-AUG-2021, ADDITIONAL INFORMATION WAS PROVIDED VIA A CONSUMER. THE CONSUMER NOTED THAT SHE DID NOT USE THE PRODUCT AND DID NOT GET ANY OF THE LEAKING PRODUCT ON HER. WHEN SHE SAW THE PRODUCT, IT DID NOT LOOK LIKE AS WHAT SHE EXPECTED. SHE PUT THE PRODUCT ON THE TOWEL TO SEE IF IT WOULD GET HOT. THE PRODUCT WAS NOTED TO HARDLY GET WARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480516 ↗
• InjuryAug 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 05-AUG-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING AN (B)(6) FEMALE CONSUMER WHO USED THERMACARE JOINT THERAPY 8 HR 4 CT (LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED). MEDICAL HISTORY INCLUDED ANXIETY, ACID REFLUX, DIURETIC THERAPY, HYPERTENSION, MUSCLE RELAXATION THERAPY, BACK PAIN, CHOLESTEROL (NOT FURTHER SPECIFIED), RESTLESS LEGS, BLADDER FREQUENCY, THERMACARE USE FOR 20 YEARS (WITHOUT INCIDENT), AND PROPHYLACTIC THERAPY FOR UTIS (URINARY TRACT INFECTION). CONCOMITANT PRODUCTS INCLUDED NADOLOL, AMLODIPINE, AND BENAZEPRIL FOR HYPERTENSION; BACLOFEN FOR MUSCLE RELAXATION; MELOXICAM AND OXYCODONE FOR BACK PAIN; PRAVASTATIN FOR CHOLESTEROL; ROPINIROLE FOR RESTLESS LEGS; TOLTERODINE FOR BLADDER FREQUENCY; ALPRAZOLAM AND FLUOXETINE FOR ANXIETY; AND VITAMIN C, VITAMIN D, A MULTIVITAMIN, AND CALCIUM FOR NUTRITIONAL SUPPLEMENTATION. ON (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED ON THERMACARE JOINT THERAPY 8 HR DIRECTLY TO HER SKIN ON HER LEFT KNEE FOR KNEE PAIN. SHE LEFT THE PRODUCT ON FOR APPROXIMATELY 8 HOURS. WHEN SHE TOOK THE PRODUCT OF, THE AREA WAS REDDENED. WITHIN ONE TO TWO WEEKS, SHE CONSUMER SHOWED THE APPLICATION AREA TO H

  Patient problems: Full thickness (Third Degree) Burn; Pain

  MAUDE report 12365380 ↗
• InjuryMay 20, 2021Off-Label Use; Off-Label Use

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A CONSUMER WHO USED THE THERMACARE JOINT THERAPY 8HR 4CT (LOT NUMBER: 20119, EXPIRATION DATE: NOV-2017). MEDICAL HISTORY INCLUDED TYPE 2 DIABETES, HYPERTENSION, SEASONAL ALLERGIES WITH NASAL CONGESTION, AND ALLERGIES TO AMOXICILLIN, PENICILLIN, AN UNSPECIFIED ANESTHETIC MEDICATION, AND SULFONAMIDES. SHE HAD SEEN AN ALLERGIST PREVIOUSLY. CONCOMITANT PRODUCTS INCLUDED ALLEGRA (FEXOFENADINE) FOR SEASONAL ALLERGIES, METFORMIN FOR DIABETES, GLIMEPIRIDE FOR DIABETES, LISINOPRIL, AND AMLODIPINE, FENOFIBRATE, AND METOPROLOL FOR HYPERTENSION. AT 8 PM ON (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED THE THERMACARE JOINT THERAPY 8HR HEAT WRAP. AT APPROXIMATELY 11:30 PM THE SAME NIGHT, SHE DEVELOPED ITCHING AT THE APPLICATION SITE. THE ITCHING PROGRESSED TO FULL BODY ITCHING. SHE DEVELOPED RAISED WELTS IN PATCHES ALL OVER HER BODY, VOMITING, SWELLING OF HER HANDS, FACE, AND EARS. HER THROAT FELT DRY AND SHE THOUGHT IT SWELLED. SHE FELT HOT. FOR TREATMENT, SHE TOOK 2 ALLEGRA RIGHT AWAY. AFTER 45 MINUTES LATER, BECAUSE HER SYMPTOMS DID NOT IMPROVE, SHE TOOK 4 BENADRYL (DIPHENHYDRAMINE). SHE HAD MARKS

  Patient problems: Burn(s); Hypersensitivity/Allergic reaction; Scar Tissue; Vomiting

  MAUDE report 11859827 ↗
• MalfunctionApr 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021 , A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A FEMALE OF UNKNOWN AGE WHO WAS USING THE THERMACARE JOINT THERAPY 8HR 4CT. MEDICAL HISTORY AND INFORMATION REGARDING USAGE OF CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER OPENED HER LAST FEW PACKAGES OF THERMACARE JOINT THERAPY 8HR 4CT (LOT NUMBER: LDY5938067042048; EXPIRATION DATE 30-APR-2023), THE LIQUID DRIPPED OFF THE PATCH AND GOT ON HER HANDS. AS OF 01-APR-2021, NO ADDITIONAL INFORMATION WAS PROVIDED AS THE CONSUMER DECLINED FURTHER PARTICIPATION.

  Patient problems: Insufficient Information

  MAUDE report 11741326 ↗
• MalfunctionOct 31, 2019Unintended Ejection

  EVENT VERBATIM [PREFERRED TERM] THE BLACK POWDER CAME UP OFF ITS LIKE IT INITIATED A HEAT BUT IT WAS IN THE FORM OF BLACK POWDER [DEVICE LEAKAGE] , . CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTING FOR MOTHER. A (B)(6) FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN), LOT NUMBER: J52765, EXPIRY DATE: APR2017, NDC NUMBER: 0573301724, UPC NUMBER: (B)(4), FROM UNKNOWN DATE FOR NECK. MEDICAL HISTORY WAS NONE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT HAD USED THERMACARE HEAT WRAPS FOR AS LONG AS THEY BEEN OUT (IN THE MARKET). SHE WAS PROBABLY BEEN USING IT FOR ABOUT FOUR TO FIVE YEARS. SHE JUST OPENED A BRAND NEW BOX AND OPENED ONE PACKAGE OUT OF THAT BOX AND WHEN SHE TOOK THE PACKAGING OFF OF IT TO USE IT A BLACK POWDER CAME OUT OF IT. AND SHE OPENED ONE OF THEM AND WHEN SHE TOOK THE PACKAGING OFF THE BLACK POWDER CAME UP OFF ITS LIKE IT INITIATED A HEAT BUT IT WAS IN THE FORM OF BLACK POWDER. THE ACTION TAKEN IN RESPONSE TO THE EVENT OF THE PRODUCT WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS UNKNOWN. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: INVESTIGATION SUMMARY: THE ROOT CAUSE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9259827 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem

  EVENT VERBATIM [PREFERRED TERM] BURN BLISTERS [BURNS SECOND DEGREE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), UPC NUMBER: (B)(4), FROM AN UNSPECIFIED DATE AT UNKNOWN FREQUENCY FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT STATED "I'M CONTACTING YOU TO LET YOU KNOW THAT I INCURRED SEVERAL BURN BLISTERS ON MY CALF FROM THE USE OF A ADVANCED JOINT PAIN THERAPY HEATWRAP". THE ACTION TAKEN IN RESPONSE TO THE EVENT WAS UNKNOWN, THE OUTCOME OF THE EVENT UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT BURNS SECOND DEGREE AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT BURNS SECOND DEGREE AS DE

  Patient problems: Partial thickness (Second Degree) Burn; Swelling

  MAUDE report 8554831 ↗
• InjuryOct 29, 2018Improper or Incorrect Procedure or Method

  EVENT VERBATIM [PREFERRED TERM] WHEN SHE TOOK IT OFF, THERE WAS A BIG WELT WHERE IT HAD BEEN, IT LOOKED LIKE A HIVE, BUT IT BURNED AND HAD A HEAD ON IT, LIKE A HOLE, BUT IT DIDN'T LOOK LIKE A PIMPLE. THE BURNING WAS HORRIBLE. [THERMAL BURN], DID NOT CHECK THE SKIN UNDER THE PRODUCT WHILE WEARING/APPLIED DIRECTLY TO SKIN /HAVE ONGOING DIABETES/READ THE USAGE INSTRUCTIONS BEFORE USING THE PRODUCT [INTENTIONAL DEVICE MISUSE]. THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A (B)(6) YEAR-OLD NON-PREGNANT FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN) (DEVICE LOT NUMBER S16667, EXPIRATION DATE JAN2020, UPC NUMBER: (B)(4)) FROM AROUND (B)(6) 2018 APPLIED DIRECTLY TO SKIN AT BASE OF NECK WHERE THE HAIRLINE STOPS FOR 8 HOURS FOR OSTEOARTHRITIS PAIN AND STIFFNESS IN HER NECK. MEDICAL HISTORY INCLUDED ONGOING DIABETES DIAGNOSED ABOUT 10-11 YEARS AGO APPROXIMATELY, ONGOING POST-MENOPAUSAL. THE PATIENT WAS CURRENTLY UNDER THE CARE OF A PHYSICIAN, SHE SAW HER PRIMARY CARE PHYSICIAN EVERY 3 MONTHS FOR REGULAR CHECK-UPS REGARDING HER DIABETES AND OSTEOARTHRITIS. THE SKIN TONE CLASSIFIED AS MEDIUM (NEITHER LIGHT NOR DARK),

  Patient problems: Burn, Thermal

  MAUDE report 8016201 ↗