BEUDAMED
    FDA Adverse Event Summary report: N

    HEM-O-LOK CLIP

    MDR report key: 3040133 · Received April 3, 2013

    Report

    Report Number
    MW5029629
    Date Received
    April 3, 2013
    Date of Event
    July 15, 2008
    Report Date
    March 26, 2013
    Manufacturer
    TELEFLEX MEDICAL (A/K/A WECK)
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, I, (B)(6), HAD A MIGRATED HEM-O-LOK CLIP, THE PRESENCE OF WHICH WAS TOTALLY UNKNOWN TO ME, REMOVED FROM MY URETHRA ((B)(6)). THE RADIOLUCENT FOREIGN DEVICE WAS IN MY BODY AS THE RESULT OF ROBOTIC SURGERY IN (B)(6) (DR (B)(6)) ON (B)(6) 2008 TO REMOVE MY CANCEROUS PROSTATE. SUBSEQUENTLY I HAVE HAD ONE BNC IN (B)(6) 2009 ((B)(6)); SUBSEQUENT RADIATION (B)(6) 2009 BECAUSE OF A POSITIVE MARGIN (RADIATION ONCOLOGIST DR (B)(6) IN (B)(6)); AND WHAT WAS SUPPOSED TO BE A BNC ON (B)(6) 2012, WHICH RESULTED IN THE AFORESAID DISCOVERY DURING SURGERY OF THE CLIP. THE BNC AS WELL AS THE SURGICAL REMOVAL OF THE CLIP WERE BOTH COMPLETED. THE CLIP IS IN CUSTODY OF LOCAL HOSPITAL ((B)(6)) FOR SOME PERCEIVED CHAIN OF CUSTODY ISSUES, WHICH WILL EXPIRE ON OR BEFORE (B)(6) 2013. I DO NOT KNOW THE DATE OF MANUFACTURE, SERIAL NUMBER, OR DISTRIBUTOR'S NAME. I DO KNOW THE CLIPS ARE INDICATED IN SIZE LIKE: .2, .4, .6, ETC. I DO NOT KNOW WHERE EXTRA LARGE FITS INTO THE SCALE THAT IS APPARENTLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136301 HEM-O-LOK CLIP HEM-O-LOK CLIP FZP TELEFLEX MEDICAL (A/K/A WECK) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Disability