BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3931563 · Received June 23, 2014

    Report

    Report Number
    3006556115-2014-00301
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED AN INFECTION. THE PT PRESENTED WITH REDNESS AND SWELLING OVER THE IMPLANT SITE. THE PT'S DEVICE WAS EXPLANTED. THE PT WILL BE REIMPLANTED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364575 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO Required Intervention