BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE SKIN STAPLER -35 WIDE-

    MDR report key: 2182308 · Received July 22, 2011

    Report

    Report Number
    MW5021508
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ETHICON
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SKIN STAPLER FAILED TO FIRE DURING APPLICATION OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE SKIN STAPLER -35 WIDE- PROXIMATE SKIN STAPLER -35 WIDE- GDT ETHICON PXW35 H43Y42
    2 PROXIMATE SKIN STAPLER -35 WIDE- PROXIMATE SKIN STAPLER -35 WIDE- GDT ETHICON PXW35 H43Y64

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR