BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS INTUIS S HEARING INSTRUMENT

    MDR report key: 2667167 · Received July 17, 2007

    Report

    Report Number
    2217809-2007-00001
    Event Type
    Other
    Date Received
    July 17, 2007
    Date of Event
    June 27, 2007
    Report Date
    July 16, 2007
    Manufacturer
    SIEMENS
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2007, SIEMENS HEARING INSTRUMENTS WAS NOTIFIED VIA E-MAIL OF AN ADVERSE EVENT IN (B)(6) INVOLVING THE SIEMENS INTUIS S HEARING INSTRUMENT. THE INCIDENT INVOLVED A (B)(6) MALE WHO ALLEGEDLY SEPARATED THE EARHOOK FROM THE INTUIS S BTE HEARING INSTRUMENT AND SWALLOWED THE HEARING INSTRUMENT. THE PT'S PARENT APPLIED FIRST RESPONSE PROCEDURE AND WAS ABLE TO DISLODGE THE HEARING INSTRUMENT BY APPLYING THREE HARD PATS TO THE BACK AND HOLDING THE PT'S HEAD DOWN IN LINE WITH GRAVITY. THE PT WAS TAKEN TO A DOCTOR WHO ADVISED REST AND ANTIBIOTICS IN CASE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS INTUIS S HEARING INSTRUMENT BEHIND-THE-EAR (BTE) HEARING INSTRUMENT ESD SIEMENS INTUIS S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Other