BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECKER FCP 1.5X5MM CUP UP

    MDR report key: 3131181 · Received July 18, 2008

    Report

    Report Number
    2430952-2008-00025
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Product Code
    HTX
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). CORRESPONDENCE SHOULD BE SENT TO: (B)(4), ATTENTION: CORPORATE COMPLAINTS COORDINATOR.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DECKER FCP 1.5X5MM CUP UP IVD RONGEURS HTX

    Patients

    Seq Age Sex Outcome Treatment
    1