BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK VISISTAT 35W 6/BOX

    MDR report key: 2900880 · Received December 12, 2012

    Report

    Report Number
    3003898360-2012-00567
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 21, 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

    A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ANY ISSUES RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT DESCRIPTION: THE STAPLER JAMMED DURING USE IN THE PROCEDURE. THE EVENT CAUSED NO HARM TO THE PT. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK VISISTAT 35W 6/BOX SKIN STAPLER GDT TELEFLEX MEDICAL 528235 01H1100548

    Patients

    Seq Age Sex Outcome Treatment
    1