BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE LOWER BACK AND HIP (THERMACARE HEATWRAP) WRAP

    MDR report key: 3131295 · Received May 21, 2013

    Report

    Report Number
    1066015-2013-00005
    Event Type
    Other
    Date Received
    May 21, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 17, 2013
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CASE COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS CASE, A REASONABLE ASSOCIATION BETWEEN THE SUSPECT PRODUCT TO THE REPORTED EVENTS THIRD DEGREE BURN DEVICE MISUSE AND BLISTER CANNOT BE EXCLUDED. THIS CASE IS REPORTABLE AS AN INITIAL 30 DAY REPORT.

    Description of Event or Problem · 1

    NOT USING THE HEATWRAP AS RECOMMENDED [DEVICE MISUSE]. THIRD DEGREE BURN, ESTIMATED TO BE APPROXIMATELY 2 INCHES IN SIZE [BURNS THIRD DEGREE], BLISTERED [BLISTER]. CASE DESCRIPTION: THIS IS AN INITIAL SPONTANEOUS REPORT FROM A CONTACTABLE NURSE. NURSE HAD REPORTED FOR A CURRENTLY (B)(6), FEMALE CONSUMER WHO STARTED USING THERMACARE HEATWRAP (THERMACARE LOWER BACK AND HIP, WRAP) (LOT NUMBER: G844130112, EXPIRATION DATE: DEC 2015) SINCE THREE YEARS AGO, OFF AND ON, FOR 24 HOURS FOR ACHING JOINTS, SORE MUSCLES AND PINCHED NERVES. RELEVANT MEDICAL HISTORY INCLUDED A RECURRING MUSCLE TENDON PINCH, A LONG WORK HISTORY OF LIFTING HEAVY OBJECTS, WITHIN THE WORK ENVIRONMENT AND REPETITIVE TURNING AND HOLDING OF HEAVY OBJECTS. CONCOMITANT MEDICATIONS WERE NONE. IT WAS REPORTED THAT SINCE AN UNKNOWN DATE CONSUMER WAS NOT USING THE HEATWRAP AS RECOMMENDED AS IT WAS REPORTED THAT SHE USED THE HEATWRAP OFF AND ON FOR 24 HOURS. ON (B)(6) 2013, THE CONSUMER EXPERIENCED A HOT SPOT ON HER LEFT HIP. THIS HOT SPOT WAS LATER REPORTED AS A THIRD DEGREE BURN WHICH BLISTERED, WAS ITCHY, RED, SWOLLEN AND PUFFY. THE BURN WAS ESTIMATED TO BE APPROXIMATELY 2 INCHES IN SIZE. RELEVANT LAB TESTS WERE UNKNOWN. THE HEATWRAP THERAPY WAS DISCONTINUED ON (B)(6) 2013. THE CONSUMER WAS TREATED WITH A BURN PATCH APPLIED WITH BREATHABLE GAUZE AND "COBAN". SURGICAL INTERVENTION SUCH AS DEBRIDEMENT WAS NOT REQUIRED. SHE WAS SLOWLY RECOVERING (REPORTED AS APPROXIMATELY 78% RECOVERED) FROM THE HOT SPOT AND REPORTED THE LIKELIHOOD OF SCARRING AT THE HOT SPOT SITE. THE CONSUMER WAS ADVISED TO VISIT A PHYSICIAN FOR HER LEFT HIP DISCOMFORT. THE STATUS OF THE OTHER REPORTED EVENT WAS UNKNOWN AT THE TIME OF THE REPORT. THE PATIENT WAS NOT TAKING ANY MEDICATIONS INCLUDING TOPICAL MEDICATIONS AT THE TIME OF THE ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP ((B)(6) 2013): NEW INFORMATION RECEIVED FROM A CONTACTABLE NURSE INCLUDED THERAPY STOP DATE, RELEVANT MEDICAL HISTORY, EVENT ONSET DATE, EVENT OUTCOME, SUSPECT PRODUCT DOSE REGIMEN, THE PATIENT'S CLINICAL COURSE AND AN ADDITIONAL EVENT OF THIRD DEGREE BURN UPGRADING THIS CASE TO REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225539 THERMACARE LOWER BACK AND HIP (THERMACARE HEATWRAP) WRAP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE G844130112

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention