BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER

    MDR report key: 1673193 · Received May 3, 2010

    Report

    Report Number
    2025182-2010-00002
    Event Type
    Other
    Date Received
    May 3, 2010
    Date of Event
    March 22, 2010
    Report Date
    April 30, 2010
    Manufacturer
    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: DEVICE 1 & 2: EXAMINATION OF THE RETURNED DEVICE REVEALED IT TO BE CLEAN AND INTACT. THE VALVE STRAP WAS NOTED TO BE INTACT. THE DEVICE WAS AIR BACK FLOW TESTED AND PASSED. QUALITY ENGINEERING WAS UNABLE TO DETERMINE THE PRECISE CAUSE OF THE TRACHEAL FLANGE CAUSED IRRITATION. NO OTHER ANOMALIES WERE NOTED. EVALUATED BY: (B)(4), PRODUCT ANALYST ENGINEER. DATE: (B)(4) 2010.

    Description of Event or Problem · 1

    RECEIVED CUSTOMER COMPLAINT INTERNALLY ON (B)(6) 2010. PT EXPERIENCED IRRITATION AND SWELLING OF FISTULA. PT'S CLINICAL IDENTIFIED THAT HE WAS EXPERIENCING TISSUE SENSITIVITY THAT WAS UNRELATED TO USE OF THE VOICE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM-SINGER VOICE PROSTHESIS EWL HELIX MEDICAL, LLC 11.251.06 879651

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other