BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PGX 35W SKIN STAPLER

    MDR report key: 6390812 · Received March 7, 2017

    Report

    Report Number
    MW5068351
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    March 7, 2017
    Report Date
    March 7, 2017
    Manufacturer
    3M
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(4) PLASTIC MAJOR PACK, 3M PRECISE PGX 35W SKIN STAPLER JAMMED AND WOULD NOT FIRE STAPLES. DIAGNOSIS OR REASON FOR USE: BILATERAL BREAST REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168747 PRECISE PGX 35W SKIN STAPLER SKIN STAPLER GAG 3M DYNJ49360 16IB9846

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR (B)(4) PLASTIC MAJOR PACK