BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35 R 6/BOX

    MDR report key: 3102068 · Received May 3, 2013

    Report

    Report Number
    3003898360-2013-00128
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE HAS NOT ARRIVED FOR INVESTIGATION. THE MFR WILL CONTINUE TO TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: STAPLER FIRED 3-4 STAPLES AT ONCE DURING USE ON A PATIENT, SO STAPLER JAMMED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194073 VISISTAT 35 R 6/BOX SKIN STAPLER GDT TELEFLEX MEDICAL 01C1200162

    Patients

    Seq Age Sex Outcome Treatment
    1