BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER

    MDR report key: 5680734 · Received May 25, 2016

    Report

    Report Number
    2025182-2016-00004
    Event Type
    Injury
    Date Received
    May 25, 2016
    Date of Event
    March 26, 2016
    Report Date
    May 25, 2016
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    COMPLAINT WAS RECEIVED FROM (B)(6) MEDICAL CENTER FROM AN SLP THAT STATED ONE OF THEIR PATIENT'S DISLODGED THEIR PROSTHESIS AND THE PROSTHESIS/RADIOPAUE RING WAS NOT VISIBLE UNDER FLOURO OR X-RAY. THE PROSTHESIS WAS NOT FOUND UNTIL APPROXIMATELY 1 MONTH LATER, WHEN THE PATIENT UNDERWENT A CT SCAN. THE PATIENT WAS QUITE ILL DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332520 BLOM-SINGER VOICE PROSTHESIS EWL FREUDENBERG MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention