BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDMOND DIAMOND KERR 4 OUP 8"3M

    MDR report key: 613773 · Received June 1, 2005

    Report

    Report Number
    3003418325-2005-00003
    Event Type
    Malfunction
    Date Received
    June 1, 2005
    Report Date
    May 31, 2005
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING A PROCEDURE, THE TIP OF THE INSTRUMENT BROKE OFF. THE PHYSICIAN REMOVED THE BROKEN PIECE FROM THE PT'S SINUS CAVITY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDMOND DIAMOND KERR 4 OUP 8"3M SURGICLA INSTRUMENTS HAE INTEGRA LIFESCIENCES CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *