BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEM-O-LOK TAKEPART ENDO APPLIER

    MDR report key: 1791860 · Received August 4, 2010

    Report

    Report Number
    1044475-2010-00109
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    February 4, 2010
    Report Date
    July 4, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER - ADDITIONAL INFORMATION HAS BEEN REQUESTED TO IDENTIFY THE LOT NUMBER FOR THIS ISSUE. DATE DEVICE RETURNED TO MANUFACTURER - DEVICE SAMPLE RETURNED TO TELEFLEX MEDICAL, (B)(4), THE APPROXIMATE DATE IS (B)(4) 2010. THE RESULTS OF THE INVESTIGATION ARE INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CLIPS FALL OUT OF THE APPLIER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK TAKEPART ENDO APPLIER CLIP APPLIER GDO TELEFLEX MEDICAL NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1