BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDGE SYSTEM ELECTRODES WITH QUIK-COMBO CONNECTOR

    MDR report key: 5488593 · Received March 9, 2016

    Report

    Report Number
    5488593
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    February 29, 2016
    Report Date
    March 4, 2016
    Manufacturer
    PHYSIO-CONTROL INC., PHYSIO-CONTROL MANUFACTURING, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN DISPOSABLE DEFIBRILLATOR PADS REMOVED FROM PATIENT, ABRASION/SKIN BREAKDOWN NOTED ON SKIN. WE HAVE HAD FOUR OTHER PATIENTS EXPERIENCE THIS SINCE (B)(6). RISK MANAGEMENT WAS NOT NOTIFIED UNTIL THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146463 EDGE SYSTEM ELECTRODES WITH QUIK-COMBO CONNECTOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE), DEFIBRILLATION PADS MKJ PHYSIO-CONTROL INC., PHYSIO-CONTROL MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other