BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTACK 5MM INSTRUMENT

    MDR report key: 1630012 · Received February 19, 2010

    Report

    Report Number
    2647580-2010-00264
    Event Type
    Other
    Date Received
    February 19, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 19, 2010
    Manufacturer
    PONCE - USS
    Product Code
    KOG
    PMA / PMN Number
    K963999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE INITIAL REPORT SENT: (B)(6) 2010. THIS REPORTED LOT NUMBER IS SUBJECT TO THE RECALL INITIATED (B)(4), 2010, THEREFORE, THIS REPORT REQUIRES A 5 DAY MDR BASED ON THIS NEW INFORMATION.

    Description of Event or Problem · 1

    PROCEDURE TYPE: VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: UPON FIRING, THE 3 DEVICES LOCKED UP AND WOULD NOT DEPLOY ANY TACKS. OPENED A NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO REPORT OF PATIENT INJURY, UNANTICIPATED BLOOD/TISSUE LOSS, OR EXTENDED OPERATING ROOM TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTACK 5MM INSTRUMENT DISPOSABLE SURGICAL ACCESS DEVICE KOG PONCE - USS P9M0312

    Patients

    Seq Age Sex Outcome Treatment
    1