BEUDAMED
    FDA Adverse Event Other Summary report: N

    7384-FOV CIRCUMCISION KIT

    MDR report key: 439699 · Received January 24, 2003

    Report

    Report Number
    1282497-2003-00025
    Event Type
    Other
    Date Received
    January 24, 2003
    Date of Event
    December 1, 2002
    Report Date
    December 20, 2002
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    GEN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER HAD A PROBLEM WITH A CIRCUMISION TRAY. ACCORDING TO THE CUSTOMER, VELCRO RESTRAINT STRAPS HAD VELCRO SEWN BACKWARDS. IN ADDITION THE STRAPS WERE LONGER THAN THEY USED TO BE. ACCORDING TO THE CUSTOMER THE BABY WAS ABLE TO MOVE AND WAS CUT DURING THE PROCEDURE. IT WAS NOT REPORTED WHERE OR TO WHAT EXTENT THE INJURY WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7384-FOV CIRCUMCISION KIT * GEN TYCO HEALTHCARE/KENDALL * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other