BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDMOND DIAMOND KERR 4 OUP 8"2M

    MDR report key: 498122 · Received November 20, 2003

    Report

    Report Number
    1121308-2003-00044
    Event Type
    Malfunction
    Date Received
    November 20, 2003
    Report Date
    November 20, 2003
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY CLAIMS THAT THE KERRISON INSTRUMENT IS GETTING JAMMED AND BONE IS GETTING CAUGHT IN THE CHANNEL OF THE INSTRUMENT. THE USER FACILITY REPORTED THE INSTRUMENT HAS AN EXTRA COATING AND SHOULD NOT BE STICKING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDMOND DIAMOND KERR 4 OUP 8"2M NON-POWERED SURGICAL INSTRUMENT HAE INTEGRA LIFESCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *