BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER INDWELLING VOICE PROSTHESIS

    MDR report key: 441220 · Received January 31, 2003

    Report

    Report Number
    2025182-2003-00001
    Event Type
    Other
    Date Received
    January 31, 2003
    Date of Event
    January 2, 2003
    Report Date
    January 10, 2003
    Manufacturer
    HELIX MEDICAL, INC.
    Product Code
    EWL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT WAS FLUSHING THEIR VOICE PROSTHESIS WHILE IN-SITU AND PUSHED IT INTO THEIR ESOPHAGUS. THE NEXT DAY THEY SAW THEIR PHYSICIAN, AND AFTER EXAMINING THEM, THE DOCTOR TOLD THEM THAT THE VOICE PROSTHESIS WILL PASS THROUGH THEIR SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other