BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE SKIN STAPLER

    MDR report key: 4109229 · Received September 15, 2014

    Report

    Report Number
    MW5038252
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    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

    PGX 35W SKIN STAPLER FROM CARDINAL HEALTH STERILE PLASTIC MAJOR PACK (B)(4) WILL NOT FIRE. DIAGNOSIS OR REASON FOR USE: PANNICULECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570438 PRECISE SKIN STAPLER STAPLER GDT 3M PGX 35W 289812

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR