BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-DETEK

    MDR report key: 235264 · Received August 10, 1999

    Report

    Report Number
    1218058-1999-00002
    Event Type
    Malfunction
    Date Received
    August 10, 1999
    Date of Event
    June 16, 1999
    Report Date
    July 27, 1999
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHILE DEFIBRILLATING PT, A BURN 1.5" IN SIZE OCCURRED UNDER THE STERNUM PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-DETEK DEFIBRILLATION ELECTRODES LDD BIO-DETEK, INC. Z1600 0299

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other