BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER CLASSIC INDWELLING

    MDR report key: 4736234 · Received April 27, 2015

    Report

    Report Number
    2025182-2015-00003
    Event Type
    Injury
    Date Received
    April 27, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 24, 2015
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K991587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE (IFU) WHICH ACCOMPANY EACH PRODUCT DETAIL VOICE PROSTHESIS DISLODGEMENT, AND THAT: "CARE MUST BE EXERCISED DURING PROSTHESIS INSERTION OR REMOVAL TO AVOID INJURY TO THE TEP OR ACCIDENTAL DISPLACEMENT OF THE PROTHESIS WHICH COULD RESULT IN ASPIRATION OF THE PROSTHESIS INTO THE TRACHEA." ALSO DETAILED IN COMPLICATIONS SECTION OF THE IFU WARNS OF "INGESTION OF THE PROSTHESIS INTO THE ESOPHAGUS AND/OR GI TRACT". THE PROTHESIS WILL NOT BE MADE AVAILABLE FOR EVALUATION AS PER THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE PATIENT'S FAMILY CALLED TO REPORT THAT THE PATIENT WOKE UP WITHOUT THEIR VOICE PROSTHESIS IN PLACE, AND WAS UNSURE IF IT "FELL OUT OR WAS SWALLOWED". THE PATIENT THEN HAD AN X-RAY PERFORMED THE SAME DAY AND CONFIRMED THE PROTHESIS WAS NOT LOCATED IN THE LUNGS. THE PATIENT HAD A CATHETER PLACED AND WAS SCHEDULED TO HAVE A NEW VOICE PROSTHESIS PLACED THE NEXT DAY. AS THE VOICE PROSTHESIS CANNOT BE LOCATED, IT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276111 BLOM-SINGER CLASSIC INDWELLING EWL HELIX MEDICAL, LLC IN2006-NS 0000003154

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention