BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMANS MOTION HEARING AID

    MDR report key: 5044889 · Received August 25, 2015

    Report

    Report Number
    3005019184-2015-00001
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    July 17, 2015
    Report Date
    August 24, 2015
    Manufacturer
    SIVANTOS GMBH
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HEARING AID DISPENSER INCORRECTLY DISPENSED A SIEMENS BRAND MOTION SA 3BX HEARING AID TO A PATIENT UNDER 3 YEARS OLD IN CONTRADICTION TO THE LABELING THAT INDICATES THE HEARING AID IS NOT SUITABLE FOR CHILDREN YOUNGER THAN 3 YEARS OLD. LABELING IN (B)(4) AS WELL AS U.S. CLEARLY INDICATES HEARING AID IS NOT SUITABLE FOR CHILDREN YOUNGER THAN 3 YEARS OLD. DISPENSER WAS NOTIFIED THAT THE MOTION SA 3BX IS NOT SUITABLE FOR CHILDREN UNDER 36 MONTHS AND INSTRUCTED WHERE THIS IS INDICATED IN THE LABELING.

    Description of Event or Problem · 1

    (B)(4) HEARING AID DISPENSER INCORRECTLY DISPENSED A SIEMENS BRAND MOTION SA 3BX HEARING AID TO A PATIENT UNDER 3 YEARS OLD, IN CONTRADICTION TO THE LABELING THAT INDICATES THE HEARING AID IS NOT SUITABLE FOR CHILDREN YOUNGER THAN 3 YEARS OLD. THE TEETHING (B)(6) MONTH OLD (B)(6) PATIENT WAS FIT WITH THE HEARING AID ON (B)(6) 2015. EARHOOK BROKE ON (B)(6) 2015 FOR THE FIRST TIME. EARHOOK BROKE FOR THE SECOND TIME ON (B)(6) 2015. EARHOOK BROKE FOR THE THIRD TIME OVER THE WEEKEND BETWEEN (B)(6) 2015. IN EACH INSTANCE THE EARHOOK BROKE AT HOME. THE PATIENT SWALLOWED THE EARHOOK ON THE THIRD INCIDENT. NO MEDICAL INTERVENTION WAS NECESSARY AS THE EARHOOK WAS EXCRETED NATURALLY BY THE PATIENT. NO DAMAGE TO THE PATIENT'S HEALTH. PATIENT NO LONGER WEARS HEARING AID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563485 SIEMANS MOTION HEARING AID BEHIND THE EAR HEARING AID OSM SIVANTOS GMBH MOTION SA 3BX

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO