BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 375015 · Received February 1, 2002

    Report

    Report Number
    2029203-2002-00033
    Event Type
    Injury
    Date Received
    February 1, 2002
    Date of Event
    September 1, 2001
    Report Date
    January 31, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE IMPLANT CENTER, PATIENT REPORTED THAT IN 2001 THE DEVICE EXTRUDED WHILE SHOWERING. THE DEVICE WAS REMOVED WITHOUT MEDICAL OR SURGICAL INTERVENTION. THE NEXT MONTH, THE PATIENT HAND DELIVERED THE DEVICE TO THE CENTER. AT THAT TIME, THE SURGEON CLEANED THE INFECTED WOUND. THE PHYSICIAN COULD NOT DISCERN WHETHER THE PATIENT'S INFECTION PROCEEDED OR WAS SUBSEQUENT TO THE DEVICE EXTRUSION. IN ADDITION, THERE IS NO INDICATION THAT THE IMPLANT HAD MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION AB-5100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention