BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-G IVD RONG 3X10 7" DEL STR

    MDR report key: 1162063 · Received April 25, 2008

    Report

    Report Number
    2430952-2008-00004_2
    Event Type
    Malfunction
    Date Received
    April 25, 2008
    Report Date
    February 29, 2008
    Manufacturer
    *
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A SURGICAL PROCEDURE, THE INSTRUMENT DISMANTLED. ADDITIONAL INFO HAS BEEN REQUESTED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-G IVD RONG 3X10 7" DEL STR SURGICAL INSTRUMENT HTX * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *