BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOCLIP, M20

    MDR report key: 1944222 · Received December 6, 2010

    Report

    Report Number
    3003898360-2010-00513
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CLIPS ARE NOT SEALING PROPERLY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEMOCLIP, M20 LIGATING CLIPS FZP TELEFLEX MEDICAL NA 01C1000194

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK