BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.1 DISPOSABLE GOMCO

    MDR report key: 1023743 · Received March 26, 2008

    Report

    Report Number
    1282497-2008-00007
    Event Type
    Other
    Date Received
    March 26, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 29, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    FHG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 03/18/2008 I SPOKE WITH CUSTOMER RISK MGMT WHO STATED: "INFANT HAD NO KNOWN CLOTTING PROBLEM, AVITENE WAS USED AND BLEEDING STOPPED".

    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 FOLLOWING A CIRCUMCISION PROCEDURE, LATER IN THE DAY, BLOOD WAS NOTED IN THE DIAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.1 DISPOSABLE GOMCO CIRCUMCISION DEVICE FHG TYCO HEALTHCARE/KENDALL 56421 7260042

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK