BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMOLOK CLIPS XL 6/CART 84/BOX

    MDR report key: 3121684 · Received May 9, 2013

    Report

    Report Number
    3003898360-2013-00190
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 4, 2012
    Report Date
    April 22, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE SAMPLE IS AVAILABLE FOR INVESTIGATION. LOT # UNK. DHR COULD NOT BE PERFORMED BECAUSE LOT # IS UNK. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. THE MFR WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED VIA MEDWATCH REPORT FROM FDA. COMPLAINT ALLEGES: ON (B)(6) 2008, PATIENT HAD A ROBOTIC RADICAL PROSTATECTOMY AFTER RECEIVING RADIATION THERAPY FOR CANCER OF THE PROSTATE. ON (B)(6) 2012, HE EXPERIENCED A SECOND BLADDER NECK CONTRACTURE AND WHEN THE DOCTOR WENT TO FIX THAT HE FOUND THAT A HEM-O-LOK CLIP HAD MIGRATED INTO THE URETHRA. IT WAS REMOVED WITHOUT INCIDENT. THE PT WAS CONTRACTED AND HE HAS THE CLIP IN HIS POSSESSION AND REFUSES TO SEND IT TO THE MFR FOR INVESTIGATION. HIS PHYSICIAN CONFIRMED TO THE PT THE CLIP TO BE A HEM-O-LOK X-LARGE, BUT DID NOT PROVIDE A LOT#. THE PT HAS REQUESTED THE LOT# FROM THE HOSPITAL WHERE THE PROCEDURE WAS PERFORMED. CLARIFICATION WAS MADE ON WHAT TYPE OF DISABILITY HE HAS THAT APPEARS ON THE MEDWATCH REPORT. HE DOES NOT HAVE A DISABILITY; HE STATED HE HAS "SOCIAL INCONTINENCE" AND MUST BE A PAD IN CERTAIN SITUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204880 HOMOLOK CLIPS XL 6/CART 84/BOX LIGATING CLIPS FZP TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1