BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD ULTRA BASE UNIT

    MDR report key: 3023027 · Received March 21, 2013

    Report

    Report Number
    3004608878-2013-00052
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A SLIPPAGE WITH A MAYFIELD ULTRA BASE UNIT WAS REPORTED ON AN ADULT PATIENT DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO INJURY INVOLVED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118476 MAYFIELD ULTRA BASE UNIT BASE UNITS AND ADAPTERS HBL INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1