BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 5404358 · Received December 11, 2015

    Report

    Report Number
    2020601-2015-00021
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 28, 2015
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HWC
    PMA / PMN Number
    K042078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO INDICATIONS OF SECOND SURGERY, THE OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA.

    Description of Event or Problem · 1

    UPON PT F/U, THE DOCTOR NOTICED THE ENDOTINE HAD DEPLOYED FROM THE POSTHOLE. SURGEON DID A SECOND SURGERY ON (B)(6) 2015 TO REPLACE WITH A NEW ENDOTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821616 MICROAIRE ENDOTINE FOREHEAD 3.0 HWC MICROAIRE SURGICAL INSTRUMENTS, LLC CFD-22202 165744

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention