BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER

    MDR report key: 6817229 · Received August 24, 2017

    Report

    Report Number
    2025182-2017-00003
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 10, 2017
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EWL
    UDI-DI
    00081330701111
    PMA / PMN Number
    K932120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 8/10/2017, IN AN INCORRECT FORMAT. THIS WAS INITIALLY DISCOVERED ON 8/23/2017, AND THIS IS BEING RE-SUBMITTED ON 8/24/2017.

    Description of Event or Problem · 1

    A COMPLAINT OF AN ASPIRATED PROSTHESIS NOT SHOWING UP ON X-RAY WAS REPORTED BY THE PATIENT'S SPEECH LANGUAGE PATHOLOGIST (SLP). THE SLP ADDITIONALLY REPORTED THAT THE "PROSTHESIS WAS VISUALIZED IN THE PATIENT'S BRONCHUS ON A TRACHEAL SCOPE" AND THAT THE PROSTHESIS "DID NOT SHOW UP ON X-RAY, EVEN WITH 7 VIEWS." THE X-RAYS WERE REVIEWED BY A RADIOLOGIST, ATTENDING ENT, RESIDENT ENT, AND THE SLP. A FULL BRONCHOSCOPY WAS PERFORMED ON THE PATIENT TO REMOVE THE ASPIRATED PROSTHESIS AND TO CHECK IF A PREVIOUSLY DISPLACED DEVICE WAS ASPIRATED. IT WAS CONFIRMED THAT THE PREVIOUSLY DISPLACED DEVICE HAD BEEN SWALLOWED AND ONLY 1 DEVICE WAS ASPIRATED. IT WAS CONFIRMED THAT THE DEVICES DID NOT CONTRIBUTE TO THE ASPIRATION EVENT NOR THE PREVIOUS EVENT OF SWALLOWING, AND THAT THESE EVENTS WERE RELATED TO THE PATIENT'S GRANULATION TISSUE. THE COMPLAINTANT INDICATED THAT THE DEVICE WAS DISCARDED AND THUS WOULD NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596489 BLOM-SINGER VOICE PROSTHESIS EWL FREUDENBERG MEDICAL, LLC 0000011020 00081330701111

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention