BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 4093013 · Received September 8, 2014

    Report

    Report Number
    2020601-2014-00028
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    April 10, 2013
    Report Date
    September 8, 2014
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    HWC
    PMA / PMN Number
    K060249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER A RECENT FDA INSPECTION, MICROAIRE MODIFIED OUR MDR REPORTING CRITERIA AND HAVE DETERMINED THIS SHOULD HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ULTRATINE FOREHEAD IMPLANT BROKE PRIOR TO OR UPON INSERTION INTO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550995 MICROAIRE ULTRATINE FOREHEAD 3.5 HWC MICROAIRE SURGICAL INSTRUMENTS CFD-23102 142355

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention