BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK SMALL CLIPS

    MDR report key: 1052339 · Received May 23, 2008

    Report

    Report Number
    3003898360-2008-00029
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECENTLY RECEIVED FOR EVAL. A FOLLOW-UP REPORT WILL BE SUBMITTED PENDING THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SURGEON REPORTS THAT 3-4 CLIPS USED FELL OFF. ALSO, STATING VESSELS WERE PROBABLY SMALLER THAN 1 MM AND THIS MAY HAVE BEEN REASON. NO PT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK SMALL CLIPS LIGATION CLIPS FZP TELEFLEX MEDICAL T1278091

    Patients

    Seq Age Sex Outcome Treatment
    1