BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK & HIP 8HR L/XL 2CT

    MDR report key: 13094009 · Received December 28, 2021

    Report

    Report Number
    3007593958-2021-00047
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    November 26, 2021
    Report Date
    December 13, 2021
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT BE IDENTIFIED. THE SITE INVESTIGATED THIS COMPLAINT BY REVIEWING THE DEVICE HISTORY RECORDS AND MANUFACTURING CONTROLS. THE REVIEW OF THE DEVICE HISTORY RECORDS, BATCH THERMAL RECORDS, AND PRODUCTION CONTROLS MET THE PRODUCT RELEASE CRITERIA. CONSUMER REPORTS " THE AREA HAD BECOME RED, AND SHE HAD 2 AREAS WHERE THE SKIN PEELED OFF, LIKE A SUNBURN. NO OOZING, PUSS, OR SORES WAS PRESENT. SHE STATED THAT SHE HAD SOME REDNESS AND BURNS ON HER BACK." THE CAUSE OF THE CONSUMER NOTICING "THE AREA HAD BECOME RED, AND SHE HAD 2 AREAS WHERE THE SKIN PEELED OFF, LIKE A SUNBURN. NO OOZING, PUSS, OR SORES WAS PRESENT. SHE STATED THAT SHE HAD SOME REDNESS AND BURNS ON HER BACK." IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID THE RISKS OF BURNS OR OTHER SKIN IRRITATIONS. THIS IS AN ADVERSE EVENT FOR A REDNESS AND BURNS; A RISK CALCULATION CANNOT BE DETERMINED AS THERE IS NO REASONABLE SUGGESTION OF A DEVICE MALFUNCTION. THE INITIAL REPORT IS BEING SENT LATE TO THE FDA (ON DAY 32). THE REPORT WAS READY TO SUBMIT BY DAY 25. THE FDA WAS NOTIFIED THAT THE REPORT WOULD BE SENT LATE DUE TO THE WEBTRADER CYBERSECURITY VULNERABILITY (NOTIFIED THE FDA BEFORE DAY 25). THE FDA CONFIRMED THE MITIGATION OF THE CYBER SECURITY RISK PAST BUSINESS HOURS ON 27-DEC-2021 (DAY 31) . THE CASE IS BEING PROMPTLY SUBMITTED ON THE MORNING OF 28-DEC-2021 (DAY 32). REFER TO ESG HELP DESK TICKET NUMBER (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A CONSUMER REGARDING A (B)(6) FEMALE WHO USED A THERMACARE LOWER BACK AND HIP 8HOUR L/XL HEAT WRAP. MEDICAL HISTORY INCLUDED ASTHMA. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HOUR L/XL HEAT WRAP (LOT NUMBER: GA0105; EXPIRATION DATE 31-AUG-2021) TO HER LOWER BACK. IT WAS THE FIRST TIME SHE USED THE HEAT WRAP AND SHE APPLIED IT OVER HER SHIRT. AFTER ONE HOUR THE HEAT WRAP BECAME WARM AND PROVIDED PAIN RELIEF. AFTER APPROXIMATELY 2 HOURS OF APPLICATION, THE THERMACARE LOWER BACK AND HIP BEGAN TO FEEL EXTREMELY HOT, AND IT CAUSED A PAINFUL BURNING SENSATION. SHE HAD THE DEVICE ON FOR APPROXIMATELY 4 OR 5 HOURS. SHE WENT TO THE RESTROOM AT WORK AND REMOVED THE WRAP AND TOOK A PICTURE OF THE APPLICATION SITE. THE AREA HAD BECOME RED, AND SHE HAD 2 AREAS WHERE THE SKIN PEELED OFF, LIKE A SUNBURN. NO OOZING, PUSS, OR SORES WAS PRESENT. SHE STATED THAT SHE HAD SOME REDNESS AND BURNS ON HER BACK. FOR TREATMENT SHE APPLIED NEOSPORIN AND USED GAUZE TO PROTECT IT. SHE HAD NOT USED THE DEVICE AGAIN. AS OF (B)(6) 2021, ONE SIDE OF THE APPLICATION SITE WAS ALMOST HEALED, HER OTHER SIDE HAD IMPROVED BUT IT STILL WAS TENDER, AND SHE HAD NOT SOUGHT A CONSULT WITH HER DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED. THE INITIAL REPORT IS BEING SENT LATE TO THE FDA (ON DAY 32). THE REPORT WAS READY TO SUBMIT BY DAY 25. THE FDA WAS NOTIFIED THAT THE REPORT WOULD BE SENT LATE DUE TO THE WEBTRADER CYBER SECURITY VULNERABILITY (NOTIFIED THE FDA BEFORE DAY 25). THE FDA CONFIRMED THE MITIGATION OF THE CYBER SECURITY RISK PAST BUSINESS HOURS ON (B)(6) 2021 (DAY 31) . THE CASE IS BEING PROMPTLY SUBMITTED ON THE MORNING OF (B)(6) 2021 (DAY 32). REFER TO ESG HELP DESK TICKET NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992253 THERMACARE LOWER BACK & HIP 8HR L/XL 2CT HOT OR COLD DISPOSABLE PACK. IMD ANGELINI ThermaCare HeatWraps - Lower Back & Hip GA0105 00305733010037

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention