BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER LOW PRESSURE V.P.

    MDR report key: 443676 · Received February 18, 2003

    Report

    Report Number
    2025182-2003-00003
    Event Type
    Other
    Date Received
    February 18, 2003
    Date of Event
    January 17, 2003
    Report Date
    January 22, 2003
    Manufacturer
    HELIX MEDICAL, INC.
    Product Code
    EWL
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    "PATIENT INGESTED 2 (TWO) PROSTHESES PRIOR TO THE HOLIDAYS." (EXACT DATES UNKNOWN).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other