BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PGX-35W 6.7MM X 3.9MM

    MDR report key: 3525100 · Received December 13, 2013

    Report

    Report Number
    MW5033469
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    December 11, 2013
    Report Date
    December 12, 2013
    Manufacturer
    3M
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 3M PRECISE PGX-35W DISPOSABLE SKIN STAPLER WAS REPEATEDLY JAMMING DURING A PROCEDURE. REPLACED WITH "LIKE" DEVICE WHICH FUNCTIONED WITHOUT PROBLEMS. REASON FOR USE: SURGICAL SKIN CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652274 PRECISE PGX-35W 6.7MM X 3.9MM DISPOSABLE SKIN STAPLER GDW 3M PGX-35W 2018-08JV

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR