BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJOR PACK - SKIN STAPLER PRECISE PGX 35W SKIN STAPLER

    MDR report key: 8960171 · Received September 3, 2019

    Report

    Report Number
    MW5089515
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 29, 2019
    Report Date
    August 29, 2019
    Manufacturer
    3M COMPANY, 3M HEALTH CARE
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SKIN STAPLER (PRECISE PGX 35W) IN MEDLINE MAJOR PACK JAMMED ON ATTEMPTED FIRING OF FIRST STAPLE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750718 MAJOR PACK - SKIN STAPLER PRECISE PGX 35W SKIN STAPLER STAPLE, REMOVABLE (SKIN) GDT 3M COMPANY, 3M HEALTH CARE DYNJ49354 19CBF791

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR