BEUDAMED
    FDA Adverse Event Summary report: N

    30421 3660-12S BERCHTOLD

    MDR report key: 533740 · Received March 13, 2004

    Report

    Report Number
    1282497-2004-00008
    Date Received
    March 13, 2004
    Date of Event
    February 13, 2004
    Report Date
    March 12, 2004
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    FQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A LIGHT HANDLE. THE HANDLE FELL OFF OF THE LIGHT DURING SURGERY AND HIT A PT IN THE HEAD. NO ADVERSE CONSEQUENCES NOTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30421 3660-12S BERCHTOLD LIGHT HANDLE FQP TYCO HEALTHCARE/KENDALL * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *