BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS PRISMA 2K

    MDR report key: 3766000 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00017
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    July 3, 2006
    Report Date
    December 18, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED LATE BECAUSE THE INCIDENT WAS INCORRECTLY CLASSIFIED AS NOT MDR REPORTABLE. A RETROSPECTIVE REVIEW OF COMPLAINTS, HOWEVER IDENTIFIED THIS INCIDENT AS MDR REPORTABLE. INVESTIGATION AND CONCLUSION: THE RETURNED DEVICES WERE EXAMINED. IT WAS FOUND THAT THE DEVICES WERE NOT PROPERLY LOCKED, AS DESCRIBED IN THE OPERATING INSTRUCTIONS.

    Description of Event or Problem · 1

    PRISMA 2K BATTERY DOOR WAS OPENED BY THE CHILD AND THE CHILD SWALLOWED THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667374 SIEMENS PRISMA 2K BEHIND THE EAR HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention