BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT 35W 6/BOX

    MDR report key: 3042848 · Received April 4, 2013

    Report

    Report Number
    3003898360-2013-00125
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 13, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. MFR WILL CONTINUE TO TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: STAPLER BLOCKED, ALTHOUGH THERE WERE STILL STAPLES IN THE STAPLER. SURGEON TOOK ANOTHER STAPLER. NO OTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138087 WECK VISISTAT 35W 6/BOX SKIN STAPLER GDT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1