BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER

    MDR report key: 876242 · Received July 5, 2007

    Report

    Report Number
    2025182-2007-00003
    Event Type
    Other
    Date Received
    July 5, 2007
    Date of Event
    June 4, 2007
    Report Date
    July 3, 2007
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE STILL WAITING FOR RETURN CONTACT FROM PT DR TO VERIFY IF DEVICE WAS FOUND. AT THIS TIME, THIS IS ALL THE INFO WE HAVE.

    Description of Event or Problem · 1

    RECEIVED PHONE CALL FROM PATIENT'S WIFE STATING THAT HER HUSBAND, THE PATIENT, "WAS COUGHING CONSTANTLY ON FRIDAY NIGHT AND HE COUGHS INTO A KLEENEX, FOLDS OVER AND COUGHS AGAIN INTO KLEENEX. HE DID NOT NOTICE THAT HIS VOICE PROSTHESIS WAS GONE UNTIL LATER THAT NIGHT. HE WENT TO EMERGENCY ROOM AND DR. USED SCOPE AND COULD NOT FIND THE PROSTHESIS IN HIS LUNGS." SHE ALSO STATED THAT "THEY ARE GOING TO DO AN MRI."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM-SINGER VOICE PROSTHESIS EWL HELIX MEDICAL, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention