BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTURION

    MDR report key: 691549 · Received March 7, 2006

    Report

    Report Number
    691549
    Event Type
    Other
    Date Received
    March 7, 2006
    Date of Event
    March 7, 2006
    Report Date
    March 7, 2006
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP
    Product Code
    HFX
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    DURING A CIRCUMCISION, THE CIRCUMCISION CLAMP WITH BELL FELL OFF THE PENIS. THIS RESULTED IN PATIENT BLEEDING, WHICH WAS CONTROLLED BY PRESSURE AND MEDICATION. THE DEVICE APPEARED TO BE THE APPROPRIATE SIZE FOR PATIENT. CORRECT TECHNIQUE WAS USED IN PERFORMING CIRCUMCISION. FACILITY HAD PREVIOUSLY USED NON-DISPOSABLE TRAY. WE BEGAN USING THE DISPOSABLE TRAY IN THE LAST SIX MONTHS AND HAVE HAD NO OTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION CLAMP, CIRCUMCISION HFX TRI-STATE HOSPITAL SUPPLY CORP * 508085

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA