BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER

    MDR report key: 6847174 · Received September 6, 2017

    Report

    Report Number
    2025182-2017-00006
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    July 7, 2017
    Report Date
    September 6, 2017
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EWL
    UDI-DI
    00081330701386
    PMA / PMN Number
    K932120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT INITIALLY REPORTED A COMPLAINT OF LEAKAGE AND THE DEVICE WAS RETURNED FOR EVALUATION. A LETTER WAS RECEIVED WITH THE RETURNED DEVICE REPORTING THAT THE PATIENT WAS HOSPITALIZED FOR A WEEK WITH POSSIBLE PNEUMONIA. FOLLOW-UP WITH THE COMPLAINANT WAS PERFORMED; THE COMPLAINANT BELIEVES THAT THE POSSIBLE PNEUMONIA WAS CAUSED BY THE LEAKAGE OF THE VOICE PROSTHESIS. THE COMPLAINANT DOES NOT KNOW IF THERE WAS A CONFIRMED MEDICAL DIAGNOSIS OF PNEUMONIA FOR THE PATIENT. ADDITIONALLY, THE COMPLAINANT INDICATED THAT THE PATIENT WAS TREATED WITH A "VERY STRONG ANTIBIOTIC." IT WAS ALSO MENTIONED THAT THE TREATING PHYSICIAN ADVISED THAT THE PATIENT'S CHEST X-RAY WAS "CLOUDY." FOLLOW-UP WITH THE TREATING PHYSICIAN COULD NOT BE PERFORMED BECAUSE THE NAME AND CONTACT INFORMATION OF THE TREATING PHYSICIAN WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627302 BLOM-SINGER VOICE PROSTHESIS EWL FREUDENBERG MEDICAL, LLC 0000064938 00081330701386

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization