BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 2961491 · Received February 6, 2013

    Report

    Report Number
    2961491
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    December 31, 2012
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS CLOSING SKIN WITH STAPLER. STAPLER DID NOT STAPLE PROPERLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SKIN CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49932 PROXIMATE STAPLER, SKIN GDT ETHICON ENDO-SURGERY, INC. * J4CH47

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR