BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.45 DISPOSABLE GOMCO

    MDR report key: 807211 · Received January 19, 2007

    Report

    Report Number
    1282497-2007-00001
    Event Type
    Injury
    Date Received
    January 19, 2007
    Date of Event
    December 29, 2006
    Report Date
    January 16, 2007
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    HFX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON 1/16/2007 THAT WHEN THE CUSTOMER RELEASED THE CLAMP, THEY WERE UNABLE TO MAINTAIN HEMOSTASIS AND HAD TO SUTURE. IT DID NOT "CRUSH" THE RING OF TISSUE AS IT SHOULD HAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.45 DISPOSABLE GOMCO DISPOSABLE CIRCUMCISION DEVICE HFX TYCO HEALTHCARE/KENDALL 56242 6310109

    Patients

    Seq Age Sex Outcome Treatment
    1 YR