BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK & HIP (THERMACARE HEATWRAP) WRAP

    MDR report key: 2212153 · Received July 8, 2011

    Report

    Report Number
    1066015-2011-00008
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Report Date
    June 30, 2011
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) BURNS IN LOWER BACK AND THE HIP [THERMAL BURN] DID NOT USE A CLOTH BETWEEN HER SKIN SURFACE AND HEAT WRAP [DEVICE MISUSE]. CASE DESCRIPTION: THIS IS AN INITIAL SPONTANEOUS REPORT FROM A CONTACTABLE REPORTER. THIS IS FIRST OF THE TWO REPORTS FROM THE SAME REPORTER. THE REPORTER REPORTED FOR HERSELF. A (B)(6) FEMALE PATIENT (RACE UNKNOWN) STARTED TO USE THERMACARE HEAT WRAP (THERMACARE LOWER BACK AND HIP, WRAP) ON UNKNOWN DATE IN 2011, AT AN UNKNOWN FREQUENCY TO GET RELIEF OF THE PAIN IN THE HIP. THE PAST MEDICAL HISTORY INCLUDED THAT SHE BROKE HER HIP BONE ON AN UNKNOWN DATE DUE TO WHICH SHE HAD A HIP SURGERY ON AN UNKNOWN DATE. THE RELEVANT CONCOMITANT MEDICATION WAS UNKNOWN. THE PATIENT EXPERIENCED BURNS IN LOWER BACK AND THE HIP. THE PATIENT MENTIONED THAT SHE DID NOT USE A CLOTH BETWEEN HER SKIN SURFACE AND HEAT WRAP. SHE ALSO MENTIONED THAT SHE WAS USING THE HEATWRAP FOR THE FIRST TIME. THERAPEUTIC MEASURES TAKEN, IF ANY, UNKNOWN. THE STATUS OF THERAPY WAS UNKNOWN AT THE TIME OF REPORT. THE CLINICAL OUTCOME OF THE REPORTED EVENT WAS UNKNOWN AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE LOWER BACK & HIP (THERMACARE HEATWRAP) WRAP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE E47704B

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR