BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-COAT MICRO KERRISON RONGEUR 8", 1MM BITESIZE

    MDR report key: 1204231 · Received June 24, 2008

    Report

    Report Number
    2430952-2008-00022
    Event Type
    Malfunction
    Date Received
    June 24, 2008
    Date of Event
    June 2, 2008
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. SINCE THE INSTRUMENT WAS NOT RETURNED, AND MULTIPLE MFRS COULD HAVE PROVIDED THE INVOLVED INSTRUMENT, WE ARE UNABLE TO DETERMINE THE EXACT MFR. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR, CORREPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-COAT MICRO KERRISON RONGEUR 8", 1MM BITESIZE RONGEURS HTX

    Patients

    Seq Age Sex Outcome Treatment
    1