BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 4213645 · Received September 26, 2014

    Report

    Report Number
    2020601-2014-00040
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    November 9, 2011
    Report Date
    September 25, 2014
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    HWC
    PMA / PMN Number
    K042796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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

    "BROKEN." RECEIVED FURTHER INFORMATION INDICATING THAT THE DEVICE WAS FOUND BROKEN WHEN THE PACKAGE WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600174 MICROAIRE ENDOTINE TRANSBLEPH 3.5 HWC MICROAIRE SURGICAL INSTRUMENTS CFD-080-0167 02785

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention