BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER

    MDR report key: 1071210 · Received July 3, 2008

    Report

    Report Number
    2025182-2008-00002
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    April 21, 2008
    Report Date
    July 2, 2008
    Manufacturer
    HELIX MEDICAL, LLC.
    Product Code
    EWL
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT OF ANALYSIS: EXAMINATION OF THE RETURNED DEVICE REVEALED A SIGNIFICANT ACCUMULATION OF A BROWN DRIED SUBSTANCE BETWEEN THE INNER SURFACE OF THE CENTRAL LUMEN AND THE TITANIUM RING OF THE CARTRIDGE ASSEMBLY AND WITHIN THE VALVE RECESS AREA. A LARGE MATERIAL SEPARATION WAS NOTED TO BE SLIGHTLY ABOVE THE TITANIUM RING APPEARING TORN OR RIPPED, WITH THE DISTAL FLANGE COMPLETELY MISSING. THE DEVICE WAS AIR BACK FLOW TESTED AND FAILED. THE DEVICE WAS CLEANED IN HOT RUNNING WATER, DRIED AND AGAIN AIR BACK FLOW TESTED AND FAILED. EXAMINATION OF THE DEVICE FOLLOWING CLEANING AND TEST REVEALED THE PREVIOUSLY NOTED DRIED SUBSTANCE TO HAVE BEEN REMOVED. EXAMINATION OF OPPOSITE AND CORRESPONDING EDGES OF THE MATERIAL SEPARATION REVEALED THE EDGES TO THE JAGGED AND TORN INDICATING THAT THE DEVICE HAD BEEN SUBJECTED TO FORCES AND STRESSES SUFFICIENT TO CAUSE THE MATERIAL SEPARATION. THIS WAS MOST LIKELY THE CAUSE OF THE COMPLAINT OF 'SEPARATION OF THE FLANGE FROM TUBE." NO OTHER ANOMALIES WERE NOTED. EVALUATED BY: QUALITY ENGINEERING TECH. DATE: 6/25/08.

    Description of Event or Problem · 1

    IN 2008, CLINICIAN CONTACTED OUR COMPANY INDICATED THAT ONE OF HER PTS HAD ASPIRATED A DEVICE (LETTER + PHONE CALL RECEIVED BY COMPLAINT DEPT THE SAME DAY). PT EXPERIENCE SEVERE COUGHING WHILE DRINKING A CARBONATED SODA, AND REPORTEDLY ASPIRATED THE DEVICE. DEVICE WAS REMOVED FROM RIGHT MAIN STEM BRONCHUS WITHOUT INCIDENT. PT WAS RESIZED AND FITTED WITH NEW DEVICE. PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM-SINGER VOICE PROSTHESIS EWL HELIX MEDICAL, LLC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention