BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD ULTRA BASE UNIT

    MDR report key: 3959814 · Received June 27, 2014

    Report

    Report Number
    3004608878-2014-00104
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 13, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE THIRD REPORT OF THREE FROM THE SAME FACILITY INVOLVING AN A2101 MAYFIELD ULTRA BASE UNIT THAT WAS INVOLVED IN A SLIPPAGE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376938 MAYFIELD ULTRA BASE UNIT BASE UNIT AND ADAPTERS FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1