BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-PADZ

    MDR report key: 9568812 · Received January 9, 2020

    Report

    Report Number
    9568812
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    October 25, 2019
    Report Date
    November 6, 2019
    Manufacturer
    BIO-DETEK INC.
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ZOLL DEFIB PADS CAUSING SKIN INTEGRITY ISSUES WHEN REMOVED 24HOURS POST-OP. PATIENTS ARE RECEIVING SKIN TEARS WHEN REMOVED EVEN WHEN ADHESIVE REMOVER IS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33800 PRO-PADZ PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE BIO-DETEK INC. 0919

    Patients

    Seq Age Sex Outcome Treatment
    1 Other