BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOUSE/3M SINGLE CHANNEL IMPLANT SYSTEM

    MDR report key: 3874288 · Received June 16, 2014

    Report

    Report Number
    6000034-2014-00894
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 19, 2014
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    G8000093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS A NON-USER OF THE DEVICE. THE PATIENT DEVELOPED AN INFECTION IN THE EAR RESULTING IN EXPLANTATION OF THE DEVICE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352902 HOUSE/3M SINGLE CHANNEL IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . 3M IMPLANT, HOUSE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention