BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERSILENE TAPE

    MDR report key: 6945055 · Received October 12, 2017

    Report

    Report Number
    2210968-2017-70491
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    October 1, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND SUTURE WAS USED. SUTURE WAS BROKEN DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726053 MERSILENE TAPE INSTRUMENT, SURGICAL, DISPOSABLE KDC ETHICON INC. KGM144

    Patients

    Seq Age Sex Outcome Treatment
    1