BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT 35R 6/BOX

    MDR report key: 2802493 · Received October 18, 2012

    Report

    Report Number
    3003898360-2012-00481
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 28, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER DEVICE HISTORY REPORT (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: STAPLER JAMMING AFTER FIRST STAPLE. THE STAPLER REMAINED "BLOCKED" ON THE PT'S SCALP. NO PT INJURY REPORTED. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK VISISTAT 35R 6/BOX SKIN STAPLER GDT TELEFLEX MEDICAL 01A1200383

    Patients

    Seq Age Sex Outcome Treatment
    1