BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-THERM

    MDR report key: 1153095 · Received September 8, 2008

    Report

    Report Number
    1153095
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WE HAVE HAD REPORTS OF HOT/COLD PACKS EXPLODING. AGAIN A PACK SHOULDN'T BE SO FRAGILE THAT IS GOING TO EXPLODE IS A LARGER FORCE IS APPLIED TO IT. PEOPLE USING THESE PACKS ARE USUALLY MOVING QUICKLY, TRYING TO TAKE CARE OF PATIENTS. THEY WERE NOT SMACKING THE PACKS AGAINST HARD COUNTER TOPS WHEN THEY EXPLODED. IT DOESN'T SEEM THAT IT WAS AN EXTREME AMOUNT OF FORCE THAT WAS USED TO CAUSE THE PACK TO BURST. MEDLINE IS COMING IN TO INVESTIGATE THESE REPORTS AND IS PROVIDING ME A FORMAL RESPONSE. THERE HAD BEEN REPORTS OF THE HOT PACK BEING TOO HOT AND IN SOME CASES BURSTING. THIS IS THE PACK THAT BURST ON AN EMPLOYEE. THESE PACKS WERE PULLED OFF OUR SHELVES AND PULLED FROM STOCK. THE MEDLINE ACCOUNT MANAGER WAS INVOLVED THE RETURN PROCESS. A MEMBER INTAKE SPECIALIST AT URGENCY CARE HAD AN INSTANT ICE PACK, MDS13800 EXPLODE UPON ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-THERM PACK, THERMAL, HOT IMD MEDLINE INDUSTRIES, INC. * 08079.
    2 ACCU-THERM PACK, THERMAL, COLD IMD MEDLINE INDUSTRIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *