BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON, INC.

    MDR report key: 144186 · Received January 15, 1998

    Report

    Report Number
    MW1012806
    Event Type
    Malfunction
    Date Received
    January 15, 1998
    Date of Event
    November 7, 1997
    Report Date
    January 8, 1998
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PIECE OF PROLENE MESH SHREDDED WHEN SURGEON TRIED TO INSERT IT INTO THE PT. EVENT OCCURRED DURING A HERNIA REPAIR. NO ADVERSE OUTCOME TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON, INC. Implant PROLENE MESH FTL ETHICON, INC. 6" X 6" KC2007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other