BEUDAMED
    FDA Adverse Event Summary report: N

    MICROAIRE TRANSBLEPH 3.0

    MDR report key: 5654985 · Received May 13, 2016

    Report

    Report Number
    2020601-2016-00046
    Date Received
    May 13, 2016
    Date of Event
    April 13, 2016
    Report Date
    October 3, 2017
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    HWC
    PMA / PMN Number
    K042796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIPTION PROVIDED BY THE CUSTOMER WAS NOT DETAILED ENOUGH TO CLARIFY A FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMAL CONDITIONS. A COMPLAINT HISTORY REVIEW REVEALED THAT PART# CFD-080-0177, ENDOTINE TRANSBLEPH 3.0, IS PERFORMING AS EXPECTED AND NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    DEFECTIVE IMPLANT.

    Description of Event or Problem · 1

    PER CUSTOMER, WHEN THE DOCTOR OPENED THE BOX, THE IMPLANT WAS DEFECTIVE. IT WAS NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310084 MICROAIRE TRANSBLEPH 3.0 ENDOTINE TRANSBLEPH 3.0 HWC MICROAIRE SURGICAL INSTRUMENTS CFD-080-0177 283712

    Patients

    Seq Age Sex Outcome Treatment
    1