BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER

    MDR report key: 9760174 · Received February 26, 2020

    Report

    Report Number
    2025182-2020-00001
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 25, 2020
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K930105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPEECH LANGUAGE PATHOLOGIST (SLP) CALLED IN REPORTING THAT THE PATIENT'S VOICE PROSTHESIS WAS LEAKING AND THEY WERE NOW IN THE HOSPITAL WITH PNEUMONIA. SHE STATES THE PROSTHESIS STARTED LEAKING "A LONG TIME AGO" BUT DOES NOT KNOW WHEN. SHE STATES THE PATIENT IGNORED THE LEAKING AND NEVER REPORTED IT TO (B)(6) NOR THE DOCTOR OR SLP. THE SLP PROVIDED (B)(6) WITH 3 LOT NUMBERS BUT IS UNCERTAIN WHICH ONE BELONGS TO THE LEAKING PROSTHESIS. THE DEVICE WAS REPORTED TO BE STILL INSERTED IN THE PATIENT AND IT WAS REPORTED TO NEVER BE REMOVED, DESPITE THE LEAKAGE. THE VOICE PROSTHESIS WAS NOT RETURNED FOR EVALUATION. THREE ATTEMPTS WERE MADE TO CALL AND OBTAIN SUPPLEMENTARY INFORMATION AND THE RETURN OF THE PROSTHESIS. NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218144 BLOM-SINGER VOICE PROSTHESIS EWL FREUDENBERG MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization