BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK & HIP L/XL 8HR

    MDR report key: 13790773 · Received March 17, 2022

    Report

    Report Number
    3007593958-2022-00011
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    October 1, 2021
    Report Date
    July 18, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT BE IDENTIFIED. THERE IS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER OR RETURN SAMPLE, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. NO PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID THE RISK OF BLISTERS AND OTHER SKIN IRRITATIONS. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE PACKAGED PRODUCT QUALITY.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT BE IDENTIFIED. THERE IS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER OR RETURN SAMPLE, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. NO PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID THE RISK OF BLISTERS AND OTHER SKIN IRRITATIONS. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE PACKAGED PRODUCT QUALITY. THIS IS AN ADVERSE EVENT FOR DEVICE COMES APART (EXCLUDES DAMAGED CELLS); RISK CALCULATION IS MINOR - REDUCED OR NO THERAPEUTIC BENEFIT.

    Description of Event or Problem · 0

    ON 18-FEB-2022, A SPONTANEOUS REPORT WAS RECEIVED FROM THE UNITED STATES FROM A CONSUMER VIA EMAIL REGARDING A (B)(6) FEMALE WHO USED THERMACARE LOWER BACK AND HIP L/XL 8HR HEAT WRAPS. MEDICAL HISTORY INCLUDED AN UNSPECIFIED DISABILITY. THE CONSUMER ALSO HAD CHRONIC NECK, UPPER BACK PAIN, AND LOWER BACK PAIN. THE CONSUMER'S ENTIRE SPINE AND JOINTS HAVE BEEN "BAD" FOR 28 YEARS. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED TO TOPICALLY APPLY THE THERMACARE LOWER BACK AND HIP L/XL 8HR HEAT WRAPS (LOT NUMBER AND EXPIRATION DATE NOT PROVIDED) AT A QUANTITY OF TWO TO FOUR A DAY FOR HER CHRONIC BACK PAIN. THE CONSUMER NOTED THAT THEY COULD NOT GO THROUGH A DAY WITHOUT THE PRODUCT. SHE HAS NEVER HAD ANY ISSUES PRIOR TO THE LAST FEW YEARS. SINCE THEN, SHE HAS NOTICED THAT THE PRODUCT USED TO BE MADE DIFFERENTLY AS SHE COULD TELL AFTER USING THEM FOR MANY YEARS. THE MATERIAL WAS NOW VERY THIN, AND THEY RIP EASILY. SUBSEQUENTLY, SHE HAD TO ENSURE THE PRODUCT WAS NOT ON TIGHT. THE VELCRO ALSO DID NOT STAY ON DESPITE THE PRODUCT NOT BEING ON TIGHT. THE PRODUCT TORE MANY TIMES NEXT TO THE "MAGNETS" (ASSUMED TO MEAN HEAT CELLS) WHEN SHE WRAPPED IT AROUND HER BACK. SHE WAS THIN, SO SHE DID NOT PULL OR STRETCH THE PRODUCT. THE PRODUCT WOULD KEEP TEARING IN THE SAME AREA ON EITHER SIDE BUT TYPICALLY ON THE LEFT SIDE WHERE IT WAS NEXT THE HEATING AREA. SHE WOULD THEN NOT ABLE TO USE IT, AS IT WOULD SLIDE DOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    ON 18-FEB-2022, A SPONTANEOUS REPORT WAS RECEIVED FROM THE UNITED STATES FROM A CONSUMER VIA EMAIL REGARDING A 54-YEAR-OLD FEMALE WHO USED THERMACARE LOWER BACK AND HIP L/XL 8HR HEAT WRAPS. MEDICAL HISTORY INCLUDED AN UNSPECIFIED DISABILITY. THE CONSUMER ALSO HAD CHRONIC NECK, UPPER BACK PAIN, AND LOWER BACK PAIN. THE CONSUMER'S ENTIRE SPINE AND JOINTS HAVE BEEN "BAD" FOR 28 YEARS. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED TO TOPICALLY APPLY THE THERMACARE LOWER BACK AND HIP L/XL 8HR HEAT WRAPS (LOT NUMBER AND EXPIRATION DATE NOT PROVIDED) AT A QUANTITY OF TWO TO FOUR A DAY FOR HER CHRONIC BACK PAIN. THE CONSUMER NOTED THAT THEY COULD NOT GO THROUGH A DAY WITHOUT THE PRODUCT. SHE HAS NEVER HAD ANY ISSUES PRIOR TO THE LAST FEW YEARS. SINCE THEN, SHE HAS NOTICED THAT THE PRODUCT USED TO BE MADE DIFFERENTLY AS SHE COULD TELL AFTER USING THEM FOR MANY YEARS. THE MATERIAL WAS NOW VERY THIN, AND THEY RIP EASILY. SUBSEQUENTLY, SHE HAD TO ENSURE THE PRODUCT WAS NOT ON TIGHT. THE VELCRO ALSO DID NOT STAY ON DESPITE THE PRODUCT NOT BEING ON TIGHT. THE PRODUCT TORE MANY TIMES NEXT TO THE "MAGNETS" (ASSUMED TO MEAN HEAT CELLS) WHEN SHE WRAPPED IT AROUND HER BACK. SHE WAS THIN, SO SHE DID NOT PULL OR STRETCH THE PRODUCT. THE PRODUCT WOULD KEEP TEARING IN THE SAME AREA ON EITHER SIDE BUT TYPICALLY ON THE LEFT SIDE WHERE IT WAS NEXT THE HEATING AREA. SHE WOULD THEN NOT ABLE TO USE IT, AS IT WOULD SLIDE DOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. ON 13-JUL-2022, ADDITIONAL INFORMATION WAS PROVIDED BY A CONSUMER. THE CONSUMER NOTED THAT THE PRODUCT TEARS APPROXIMATELY 4 INCHES FROM THE LEFT SIDE. THE CONSUMER NOTED THAT THE PRODUCT DID NOT LEAK ON HER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674678 THERMACARE LOWER BACK & HIP L/XL 8HR HOT OR COLD DISPOSABLE PACK. IMD ANGELINI THERMACARE HEATWRAPS - LOWER BACK & HIP 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention LISINOPRIL.| LISINOPRIL.| METOPROLOL.| METOPROLOL.| UNSPECIFIED PAIN MEDICATION.| UNSPECIFIED PAIN MEDICATION.