BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER

    MDR report key: 1532330 · Received November 16, 2009

    Report

    Report Number
    2025182-2009-00003
    Event Type
    Other
    Date Received
    November 16, 2009
    Date of Event
    September 15, 2009
    Report Date
    November 13, 2009
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE CALLED OUR COMPANY ON (B)(4) 2009. PT WAS CHARGING HIS VOICE PROSTHESIS AND DROPPED IT INTO HIS AIRWAY. PER HIS WIFE, HE HAD INSERTED THE STRAP ONTO THE INSERTER STICK INCORRECTLY. PT WAS TAKEN TO HOSPITAL; PROCEDURE TO LOCATE DEVICE WAS DONE; ALTHOUGH PT ENDED UP COUGHING DEVICE OUT. PER WIFE, PT IS SEEING SLP FOR QUESTIONS RE: INSERTION OF DEVICE & IS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention