BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM SINGER VOICE PROSTHESIS

    MDR report key: 1033387 · Received April 23, 2008

    Report

    Report Number
    MW5006366
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 3, 2008
    Report Date
    April 23, 2008
    Product Code
    EWL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MY MOTHER HAS HAD A "LARYNXECTOMY" DUE TO CANCER. SHE HAS USED A BLOOM SINGER VOICE PROTHESIS FOR THE PAST SEVERAL YEARS. SHE ASPIRATED THE DEVICE INTO HER RIGHT MAINSTEM. THE DEVICE WAS REMOVED WITH A BRONCHOSCOPE AND BIOPSY CLAMP BY HER PULMONARY DOCTOR. THE DEVICE IS RADIO OPAQUE WHILE INTACT! THIS DEVICE HAS AN INNER FLAP TO PREVENT ASPIRATION OF FLUIDS AND FOOD. THE FLAP IS NOT OPAQUE. THE FLAP CAME OUT OF THE DEVICE BEFORE OR DURING REMOVAL OF THE BLOOM SINGER. MY MOTHER HAS BEEN HOSPITALIZED FOR RECURRENCE OF ASP PNEUMONIA DUE TO A FOREIGN BODY. XRAYS HAVE BEEN PERFORMED ON THE DEVICE AND THE FLAP. ON XRAY THE FLAP DOESN'T SHOW UP. THIS PART OF THE BLOOM SINGER HASN'T BEEN RETRIEVED. THE DEVICE WAS INTACT BEFORE ASPIRATED. PLEASE HELP ME. I AM A REGISTERED RESPIRATORY THERAPIST WITH 14 YEARS EXPERIENCE. MY MOM HAD HER LARYNX REMOVED 1999. DATES OF USE: 2000 - 2008. DIAGNOSIS OR REASON FOR USE: LARYNGECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM SINGER VOICE PROSTHESIS DUCT BILL SPEAKING DEVICE EWL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R