BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEB/EKG PADS

    MDR report key: 4992986 · Received August 4, 2015

    Report

    Report Number
    MW5055267
    Event Type
    Injury
    Date Received
    August 4, 2015
    Report Date
    August 4, 2015
    Manufacturer
    HEART SYNC
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    MULTIPLE PATIENTS THAT HAVE USED HEART SYNC DEFIB/EKG PADS HAVE HAD SKIN IRRITATIONS AND "BURNS". DATES OF USE: (B)(6) 2015. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511761 DEB/EKG PADS DEFIBRILLATOR PADS MLN HEART SYNC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other