BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 4213646 · Received September 26, 2014

    Report

    Report Number
    2020601-2014-00038
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    October 4, 2011
    Report Date
    September 25, 2014
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    HWC
    PMA / PMN Number
    K041835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS BROKEN ONCE IT WAS PICKED UP WITH THE FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599928 MICROAIRE ENDOTINE MIDFACE B HWC MICROAIRE SURGICAL INSTRUMENTS CFD-020-0197 02935

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention