BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOT PACK, INSTANT, ACCUTHERM, 6X

    MDR report key: 1213742 · Received October 24, 2008

    Report

    Report Number
    1417592-2008-00036
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 22, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CLINICIAN HAD DIFFICULTY ACTIVATING THE HOT PACK AND GAVE IT TO A MEMBER OF THE MAINTENANCE STAFF TO ACTIVATE. WHEN HE ACTIVATED IT, IT BURST, SENDING THE CONTENTS INTO THE EYE OF THE STAFF MEMBER. THEY FLUSHED HER EYE WITH WATER AND SENT HER TO THE ER FOR EVALUATION. THERE WAS NO INJURY AND SHE WAS RELEASED. THE SAMPLE WAS EVALUATED. THERE IS A RUPTURE IN THE FILM ABOUT THE CENTER OF THE PACK. THE CONCLUSION IS THAT THE ACCOUNT ACTIVATED IT IMPROPERLY THIS WAS DUPLICATED WITH RESERVED SAMPLES. THE PACKS WERE ACTIVATED WITH THE FORCE OF THE WATER MOVING IN THE OPPOSITE DIRECTION OF WHAT THE INSTRUCTIONS INDICATE. TO ADDRESS THIS, THE INSTRUCTIONS ARE BEING REVISED TO FURTHER CLARIFY THIS ON THE PACKAGING.

    Description of Event or Problem · 1

    HOT PACK APPARENTLY BURST UPON ACTIVATION AND SENT CONTENTS INTO THE EYES OF THE CLINICIAN. IT WAS REPORTED THAT NO SERIOUS INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOT PACK, INSTANT, ACCUTHERM, 6X NONE IMD MEDLINE INDUSTRIES, INC. MDS139005 08112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other