BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON SMALL CLIP

    MDR report key: 1310052 · Received February 9, 2009

    Report

    Report Number
    3003898360-2009-00016
    Event Type
    Other
    Date Received
    February 9, 2009
    Report Date
    February 3, 2009
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE REQUESTED FOR EVALUATION, BUT NOT RECEIVED AT THE TIME OF THIS REPORT. INVESTIGATION RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT DESCRIPTION IS REPORTED AS: DURING A THYROIDECTOMY, THE CLIP DID NOT CLOSE WELL ON SMALL VESSELS TO THE SUPERIOR THYROID ARTERY. HEMOSTASIS OCCURRED. THE PT WAS IMMEDIATELY RE-OPERATED ON. THE CONDITION OF THE PT AFTER THE INTERVENTION WAS GOOD. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON SMALL CLIP LIGATING CLIPS FZP TELEFLEX MEDICAL NA 01B0800318

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention