BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK L LIGATION CLIPS

    MDR report key: 856831 · Received October 4, 2006

    Report

    Report Number
    3003898360-2006-00015
    Event Type
    Malfunction
    Date Received
    October 4, 2006
    Report Date
    October 4, 2006
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL BY MFR? LIGATION CLIPS WERE NOT SAVED AND RETURNED TO MFR. A LOT NUMBER (S) WAS NOT PROVIDED, THEREFORE, A DHR EVAL COULD NOT BE PERFORMED. IF ANY ADD'L INFO BECOMES AVAILABLE, TELEFLEX MEDICAL WILL PROVIDE A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TELEFLEX MEDICAL THAT DURING A PROSTATECTOMY PROCEDURE, THE HEM-O-LOK CLIPS USED MIGRATED DOWN THE VESSEL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR