BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON LIGATING CLIP APPLIER SMALL WIDE 8" CV

    MDR report key: 1181966 · Received September 22, 2008

    Report

    Report Number
    1044475-2008-00030
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Report Date
    August 27, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE REQUESTED, BUT NOT RETURNED YET. INVESTIGATION REPORT NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    PURCHASING AGENT REPORTS THAT THE HOSPITAL CALLED AND STATED HAVING AN APPLIER THAT IS NOT HOLDING THE CLIPS. NO PATIENT AND/OR USER INJURY REPORTED. NO INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON LIGATING CLIP APPLIER SMALL WIDE 8" CV LIGATION CLIP APPLIER GDO TELEFLEX MEDICAL NA 1473191-006

    Patients

    Seq Age Sex Outcome Treatment
    1