BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 4465056 · Received January 20, 2015

    Report

    Report Number
    2020601-2015-00002
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    December 18, 2014
    Report Date
    January 13, 2015
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HWC
    PMA / PMN Number
    K032770
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO INDICATION OF SECONDARY SURGERY, OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA.

    Description of Event or Problem · 1

    THE PATIENT HAD FOREHEAD SURGERY WITH ENDOTINE FOREHEAD 3.5 AT A CLINIC LOCATED IN (B)(6). THREE WEEKS LATER, THE PATIENT COMPLAINED THAT THE IMPLANT CAME OFF. (B)(6) REOPENED THE INCISION AND FOUND THE IMPLANT HAD DISLODGED FROM THE DRILLED HOLE. HE TRIED TO INSERT THE IMPLANT BUT IT DIDN'T WORK. THE DEVICE WAS EXPLANTED ON (B)(6) 2014 AND ANOTHER ENDOTINE DEVICE WAS SUCCESSFULLY IMPLANTED. AS OF THIS REPORT, THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44848 MICROAIRE ENDOTINE FOREHEAD 3.5 HWC MICROAIRE SURGICAL INSTRUMENTS, LLC CFD-22102 165598

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention