BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 4963718 · Received July 28, 2015

    Report

    Report Number
    2020601-2015-00044
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    April 16, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HWC
    PMA / PMN Number
    K060249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE DEVICE WAS EXPLANTED, THE OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT WHERE AT 2-WEEKS POST OPERATIVE, THE DOCTOR NOTICED FAILURE/BROW DESCENT. DEVICE WAS REMOVED AND SECOND SURGERY WAS PERFORMED ON (B)(6) 2015. (MICROAIRE WAS NOTIFIED OF THIS ON 06/24/2015).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491665 MICROAIRE ULTRATINE FOREHEAD 3.0 HWC MICROAIRE SURGICAL INSTRUMENTS, LLC CFD-23202 242862

    Patients

    Seq Age Sex Outcome Treatment
    1