BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER ADVANTAGE INDWELLING

    MDR report key: 842065 · Received April 19, 2007

    Report

    Report Number
    2025182-2007-00001
    Event Type
    Other
    Date Received
    April 19, 2007
    Report Date
    March 27, 2007
    Manufacturer
    INTERNATIONAL HEALTHCARE TECHNOLOGIES, A DIV OF HELIX MEDICAL, LLC
    Product Code
    EWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF ANALYSIS: EXAMINATION OF THE RETURNED DEVICE REVEALED A BLACK HUE ON THE ENTIRE DEVICE. THREE (3) MATERIAL SEPARATIONS WERE NOTED TO BE THROUGH THE CENTRAL LUMEN, LOCATED ABOVE AND ON THE VALVE CARTRIDGE ASSEMBLY. THE REMAINDER OF THE DEVICE APPEARED INTACT. THE DEVICE WAS AIR BACK FLOW TESTED AND PASSED. THE DEVICE WAS CLEANED IN HOT RUNNING WATER, DRIED AND AGAIN AIR BACK FLOW TESTED AND PASSED. EXAMINATION OF THE DEVICE FOLLOWING CLEANING AND TEST REVEALED THAT THE PREVIOUSLY NOTED BLACK HUE REMAINED. AGGRESSIVE HANDLING WAS MOST LIKELY THE CAUSE OF THE COMPLAINT OF DEVICE BECOMING DISLODGED AND FALLING INTO THE LUNGS OF THE PATIENT. NO OTHER ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    PT HAD PRE-EXISTING CONDITION OF PNEUMONIA (UNRELATED TO PROSTHESIS). PROSTHESIS FELL INTO PATIENT'S LUNGS WHILE COUGHING. PT HAD BEEN SIZED BEFORE PLACEMENT. PT WAS PUT TO SLEEP AND PROSTHESIS WAS RETRIEVED THROUGH STOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM-SINGER ADVANTAGE INDWELLING VOICE PROSTHESIS EWL INTERNATIONAL HEALTHCARE TECHNOLOGIES, A DIV OF HELIX MEDICAL, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention