BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE MIDFACE ST

    MDR report key: 5442590 · Received February 17, 2016

    Report

    Report Number
    2020601-2016-00010
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    August 28, 2014
    Report Date
    February 12, 2016
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    GAM
    PMA / PMN Number
    K032698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAIL.ABLE; REPORTED BY PATIENT.

    Description of Event or Problem · 1

    PATIENT HAD CHEEK ENHANCEMENT SURGERY ON (B)(6) 2014. SURGEON USED (B)(4), LOT #232653 AND 232753. PATIENT NOTED THE ENDOTINE'S SNAPPED IN THE FIRST WEEK AND HAS REPORTEDLY BEEN TO MULTIPLE DOCTORS SEVERAL TIMES. 18 MONTHS POST-SURGERY, PATIENT IS STILL IN PAIN. MICROAIRE WAS MADE AWARE OF THE INCIDENT ON (B)(6) 2016 AND OUR INVESTIGATION BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99595 MICROAIRE MIDFACE ST ENDOTINE MIDFACE ST 4.5 GAM MICROAIRE SURGICAL INSTRUMENTS CFD-060-0197 232653

    Patients

    Seq Age Sex Outcome Treatment
    1