BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDMOND DIAMOND KERRISON RONGUER 4 OUP 8"

    MDR report key: 419872 · Received October 3, 2002

    Report

    Report Number
    1121308-2002-00029
    Event Type
    Malfunction
    Date Received
    October 3, 2002
    Report Date
    October 3, 2002
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED. THE USER FACILITY REPORTS THE SCREW FELL OUT OF THE INSTRUMENT ONTO THE STERILE TABLE. THIS INSTRUMENT WAS SENT IN TO BE PEENED AND THE SCREW STILL FELL OUT. THE SCREW FELL OUT PRIOR TO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDMOND DIAMOND KERRISON RONGUER 4 OUP 8" SURGICAL INSTRUMENT HAE INTEGRA LIFESCIENCES CORP. * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *