BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R SKIN STAPLER

    MDR report key: 1000806 · Received February 21, 2008

    Report

    Report Number
    3003898360-2008-00010
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Report Date
    February 12, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT NO. T1264102. THE DEVICE HAS BEEN RECEIVED AND CURRENTLY BEING EVALUATED. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    THE FACILITY ALLEGES THE SKIN STAPLERS ARE JAMMING. IT IS UNK WHEN THIS CONDITION IS OCCURRING. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT 35R SKIN STAPLER SKIN STAPLER GDT TELEFLEX MEDICAL NA T1266116

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK