BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 2802495 · Received October 18, 2012

    Report

    Report Number
    3003898360-2012-00489
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 27, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE HAS NOT BEEN RECEIVED BY MANUFACTURER IN TIME FOR THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: STAPLER JAMMED AFTER THE FIRST STAPLE WAS FIRED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT 35W 6/BOX SKIN STAPLER GDT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1