BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER ADVANTAGE

    MDR report key: 5579659 · Received April 14, 2016

    Report

    Report Number
    2025182-2016-00003
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    March 24, 2016
    Report Date
    April 14, 2016
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K991587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT LOST THEIR PROSTHESIS AND REQUESTED A BRONCHOSCOPY BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232494 BLOM-SINGER ADVANTAGE VOICE PROSTHESIS EWL FREUDENBERG MEDICAL, LLC AS1606-NS 0000023077

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention