BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A.C.E. I.C.E. /HEAT HOT & COLD COMPRESS

    MDR report key: 1956223 · Received December 10, 2010

    Report

    Report Number
    2110898-2010-00149
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    3M CONSUMER HEALTH CARE
    Product Code
    IME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND RESULT: PRODUCT WAS NOT RETURNED. CONCLUSION: USER DID NOT FOLLOW THE PROPER PRODUCT DIRECTIONS FOR HOT USE. CUSTOMER DID NOT PLACE GEL PACK IN BANDAGE POCKET PRIOR TO HEATING PACK VIA THE MICRO WAVE. WHEN KNEADING THE GEL PACK, THE BANDAGE PACKET MAY HAVE CAUGHT THE GEL AND PREVENTED IT FROM REACHING THE SKIN. NOTE: BANDAGE POCKET FOR GEL PACK IS INCLUDED IN THE PRODUCT PACKAGING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THEY MICROWAVED GEL PACK FOR 30 SECONDS, REMOVED THE GEL PACK AND THE (B)(6) SON MASSAGED THE GEL PACK TO DIFFUSE THE HEAT. THE GEL PACK SPLIT AND SQUIRTED HOT GEL ONTO THE BOY'S FACE. THE PARENTS WASHED HIS FACE WITH COLD WATER TO REMOVE THE GEL. THE AREA REDDENED AND BEGAN TO BLISTER. PARENTS GAVE THEIR SON ADVIL FOR THE PAIN. THE NEXT MORNING, THE AREA HAD MORE BLISTERING. THEY TOOK THEIR SON TO THE DOCTOR WHO DIAGNOSED A SECOND DEGREE BURN. DIRECTIONS FOR HOT USE PRINTED ON OUTER COVER OF REUSABLE GEL PACK AND PACKAGE LABELING STATE: INSERT GEL PACK INTO BANDAGE POCKET AND LAY FLAT IN MICROWAVE. HEAT AT FULL POWER. (SEE SCHEDULE FOR HEATING REQUIREMENTS.) WATTAGE 800 - 40 SECONDS, 1000 - 35 SECONDS. REMOVE FROM MICROWAVE AND KNEAD FOR ONE MINUTE TO DISTRIBUTE HEAT EVENLY (TEMPERATURE WILL CONTINUE TO RISE SLIGHTLY). CHECK FOR DESIRED TEMPERATURE BY HOLDING BANDAGE AGAINST FOREARM. IF TOO HOT, ALLOW TO COOL BEFORE APPLYING. APPLY TO DESIRED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A.C.E. I.C.E. /HEAT HOT & COLD COMPRESS 890.5700 COLD PACK, IME IME 3M CONSUMER HEALTH CARE 207518 08147

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other