BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-G IVD RONG 3X10 7" DEL STR

    MDR report key: 1008030 · Received February 29, 2008

    Report

    Report Number
    2430952-2008-00004
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Report Date
    February 29, 2008
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR. THE MFR HAS BEEN NOTIFIED OF THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A SURGICAL PROCEDURE, THE INSTRUMENT DISMANTLED. ADD'L 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 HAO

    Patients

    Seq Age Sex Outcome Treatment
    1