BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER 35W

    MDR report key: 3955661 · Received June 12, 2014

    Report

    Report Number
    3003898360-2014-00400
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 14, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAG
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. DEVICE SAMPLE RECEIVED BY MFR, BUT INVESTIGATION IS STILL UNDERWAY AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ALLEGED ISSUE: THE STAPLER WORKED INITIALLY THEN "LOCKED UP". THERE WERE NO PT CONSEQUENCES. THE PT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348024 VISISTAT SKIN STAPLER 35W STAPLER GAG TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1