BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INHEALTH TECHNOLOGIES ADVANTAGE

    MDR report key: 2135647 · Received November 21, 2007

    Report

    Report Number
    2135647
    Event Type
    Injury
    Date Received
    November 21, 2007
    Date of Event
    November 19, 2007
    Report Date
    November 20, 2007
    Manufacturer
    INHEALTH TECHNOLOGIES, DIV. OF HELIX MEDICAL, LLC
    Product Code
    EWL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR EXACERBATION OF COPD. ON (B)(6) 2007 SHE NOTED THAT HER INDWELLING VOICE PROSTHESIS WAS PROTRUDING FROM THE TRACHEOESOPHAGEAL PUNCTURE SITE. ON (B)(6) 2007, SHE NOTICED THAT THE PROSTHESIS WAS GONE. XRAY CONFIRMED PRESENCE OF FOREIGN BODY IN LUNG. PT UNDERWENT A BRONCHOSCOPY (B)(6) 2007 AND THE INDWELLING PROSTHESIS WAS RETRIEVED. UPON EXAMINATION OF THE PROSTHESIS BY SLP ON (B)(6) 2007, IT WAS NOTED THAT THE ENTIRE ESOPHAGEAL FLANGE WAS MISSING. MFR NOTIFIED PER SLP ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INHEALTH TECHNOLOGIES ADVANTAGE BLOM-SINGER INDWELLING VOICE PROSTHESIS EWL INHEALTH TECHNOLOGIES, DIV. OF HELIX MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention