BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOLOK LIGATING CLIPS XL

    MDR report key: 1641274 · Received March 25, 2010

    Report

    Report Number
    3003898360-2010-00121
    Event Type
    Other
    Date Received
    March 25, 2010
    Report Date
    March 4, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF SAMPLE IS AVAILABLE. THE LOT# IS UNKNOWN. EVALUATION: PROBABLY NO SAMPLE AND NO LOT # AVAILABLE TO DO INVESTIGATION ON. CONCLUSIONS: OTHER - IF SAMPLE OR LOT # BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT AND THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A CLIP FELL IN THE PATIENT. IT WAS FOUND ON X-RAY 2 MONTHS AFTER A RADICAL PROSTATECTOMY WHEN THE PATIENT COMPLAINED OF HAVING DIFFICULTY URINATING. CLIP WAS REMOVED VIA A LAPAROSCOPE. NO FURTHER INFORMATION ON PATIENT'S CONDITION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOLOK LIGATING CLIPS XL LIGATING CLIPS FZP TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention