BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK XL POLYMER CLIPS

    MDR report key: 833664 · Received March 21, 2007

    Report

    Report Number
    3003898360-2007-00005
    Event Type
    Malfunction
    Date Received
    March 21, 2007
    Date of Event
    December 12, 2006
    Report Date
    February 20, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED TWO (2) DIFFERENT LOT NUMBERS WHEN REPORTING THIS EVENT. LOT NUMBER 200702 AND 1286821. THE DHR'S HAVE BEEN REQUESTED FOR REVIEW. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON ALLEGES DURING A LAP NEPHRECTOMY, HE PLACED TWO CLIPS ON THE PROXIMAL SIDE OF THE RENAL VEIN AND ONE CLIP ON THE DISTAL. HE NOTICED BLOOD COMING WHERE THE TWO PROXIMAL CLIPS WERE PLACED. HE PUT A COUPLE OF METAL CLIPS ON THE VIEW TO STEM THE BLOOD FLOW, CORRECTING THE CONDITION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK XL POLYMER CLIPS POLYMER LIGATION CLIPS FZP TELEFLEX MEDICAL NA 200702

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention