BEUDAMED
    FDA Adverse Event Summary report: N

    1.1 DISPOSABLE GOMCO

    MDR report key: 1023690 · Received March 26, 2008

    Report

    Report Number
    1282497-2008-00008
    Date Received
    March 26, 2008
    Report Date
    March 18, 2008
    Manufacturer
    NELLCOR
    Product Code
    FHG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 18 MAR 2008, I SPOKE WITH CUSTOMER RISK MANAGEMENT WHO STATED: " INFANT HAD NO KNOWN CLOTTING PROBLEMS, AVITENE WAS USED BLEEDING STOPPED." AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTH CARE/KENDALL IN 2008, THAT A CUSTOMER HAD A PROBLEM WITH A CIRCUMCISION DEVICE. CUSTOMER STATED THAT LATER IN THE DAY, AFTER THE CIRCUMCISION PROCEDURE, BLOOD WAS NOTED IN THE INFANT'S DIAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.1 DISPOSABLE GOMCO CIRCUMCISION DEVICE FHG NELLCOR 56421 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK