BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE SKIN STAPLER 6.70MM X 3.90MM

    MDR report key: 3542252 · Received December 24, 2013

    Report

    Report Number
    MW5033612
    Event Type
    Malfunction
    Date Received
    December 24, 2013
    Date of Event
    December 23, 2013
    Report Date
    December 23, 2013
    Manufacturer
    3M
    Product Code
    GDT
    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 WOULD NOT ACTIVATE AFTER ONLY A FEW USES. THIS WAS REPLACED WITH A "LIKE" DEVICE WHICH WORKED WITHOUT ISSUE. DIAGNOSIS OR REASON FOR USE: REDUCTION MAMMOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673968 PRECISE SKIN STAPLER 6.70MM X 3.90MM SKIN STAPLER GDT 3M PGX-35W 2018-08JF

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR