BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 107797 · Received July 2, 1997

    Report

    Report Number
    107797
    Event Type
    Injury
    Date Received
    July 2, 1997
    Date of Event
    February 18, 1997
    Report Date
    March 3, 1997
    Manufacturer
    MILTEX INSTRUMENT CO, INC.
    Product Code
    HFX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE PENIS WAS LACERATED DURING THE CIRCUMCISION, USING A NOGEN CLAMP. THE NEWBORN REQUIRED SURGERY BY A UROLOGIST TO REPAIR THE LACERATION. IT'S UNK AT THIS TIME IF ANY PERMANENT INJURY WILL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MOGEN CLAMP HFX MILTEX INSTRUMENT CO, INC. 30-3100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Hospitalization NO