BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTURION

    MDR report key: 313758 · Received January 20, 2001

    Report

    Report Number
    1824619-2001-00001
    Event Type
    Other
    Date Received
    January 20, 2001
    Date of Event
    December 11, 2000
    Report Date
    December 21, 2000
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP.
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CIRCUMCISION, THE CIRCUMCISION CLAMP SLIPPED REQUIRING SIX SUTURES TO THE INFANT'S PENIS. THE HOSP REPORTED IT TO CO'S SALES REPRESENTATIVE, WHO WAS ABLE TO VIEW THE DEVICE ON 12/21/00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686 CENTURION CIRCUMCISION CLAMP 1.1 CM HFX TRI-STATE HOSPITAL SUPPLY CORP. * 09250

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Required Intervention