BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER

    MDR report key: 6817243 · Received August 24, 2017

    Report

    Report Number
    2025182-2016-00008
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    November 28, 2016
    Report Date
    December 14, 2016
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K930105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 12/14/2016, 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

    OUR (B)(4) DISTRIBUTOR SENT AN EMAIL ON NOVEMBER 29TH, 2016 STATING A PATIENT HAD A DEVICE REMOVED FROM THEIR LUNGS. ON (B)(6) 2016, WHILE AT HOME, THE PATIENT WAS IN THE PROCESS OF INSERTING THE PATIENT CHANGEABLE VOICE PROSTHESIS WHEN THE DEVICE WENT INTO THE PATIENT'S LUNGS. THE PATIENT WENT TO THE EMERGENCY ROOM AND HAD A CHEST X-RAY WHICH RESULTED IN "NO RADIOPAQUE OR FOREIGN OBJECT " FOUND. ON THE FOLLOWING DAY, (B)(6) 2016, THE PATIENT UNDERWENT BRONCHOSCOPY WHERE THE DEVICE WAS FOUND IN THE LUNGS AND REMOVED. THERE HAVE BEEN NO FURTHER PATIENT CONSEQUENCES REPORTED DUE TO THIS EVENT. IT WAS REPORTED THE PATIENT FOLLOWED THE INSTRUCTIONS FOR USE WHEN USING THIS DEVICE. THIS WAS NOT THE PATIENT'S FIRST TIME USING THE DEVICE, AND HAD BEEN USING THIS TYPE OF DEVICE SINCE 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595995 BLOM-SINGER VOICE PROTHESIS EWL FREUDENBERG MEDICAL, LLC 0000037769

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention