BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK POLYMER CLIPS

    MDR report key: 1203534 · Received October 17, 2008

    Report

    Report Number
    3003898360-2008-00092
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    July 28, 2008
    Report Date
    September 29, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. INVESTIGATION REPORT NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE CLIPS COULD NOT BE LOCKED SHUT. THIS ISSUE WAS DETECTED PRIOR TO PT USE. NO PT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK POLYMER CLIPS POLYMER LIGATION CLIPS FZP TELEFLEX MEDICAL T126058

    Patients

    Seq Age Sex Outcome Treatment
    1