BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP (THERMACARE HEATWRAP) WRAP

    MDR report key: 2973929 · Received February 15, 2013

    Report

    Report Number
    1066015-2013-00001
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    February 5, 2013
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY COMMENT: BASED ON THE INFORMATION PROVIDED, A POSSIBLE CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT TO THE REPORTED EVENT THERMAL BURN CANNOT BE EXCLUDED. THIS CASE IS MEDICALLY ASSESSED AS REPORTABLE AS AN INITIAL 30 DAY EU REPORT.

    Description of Event or Problem · 1

    SKIN BURN [THERMAL BURN]. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHYSICIAN RECEIVED VIA A SALES REPRESENTATIVE. A MALE PATIENT OF AN UNSPECIFIED AGE AND ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK AND HIP, WRAP) VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSAGE AND FREQUENCY FOR BACK PAIN. MEDICAL HISTORY INCLUDED THERMOHYPOAESTHESIA FROM AN UNKNOWN DATE AFTER ACCIDENT AND HYPOAESTHESIA FROM AN UNKNOWN DATE AFTER ACCIDENT, AND UNKNOWN IF ONGOING. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED SKIN BURN. THERE WAS NO RELEVANT LABORATORY DATA AVAILABLE. THERAPEUTIC MEASURES TAKEN AS A RESULT OF THE SKIN BURN INCLUDED SKIN TRANSPLANTATION. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS UNKNOWN. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT HAD RECOVERED FROM THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69556 THERMACARE LOWER BACK & HIP (THERMACARE HEATWRAP) WRAP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R