BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGE TOOTHETTE PLUS

    MDR report key: 528693 · Received May 26, 2004

    Report

    Report Number
    MW1032226
    Event Type
    Injury
    Date Received
    May 26, 2004
    Date of Event
    May 17, 2004
    Report Date
    May 26, 2004
    Manufacturer
    SAGE PRODUCTS INC.
    Product Code
    JOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BRONCHOSCOPY PERFORMED TO REMOVE GREEN SPONGE TIP OF TOOTHETTE FROM PT'S LUNG. PT W/COMPROMISED SWALLOWING UNKNOWINGLY ASPIRATED THE LARGE PORTION OF THE SPONGE THAT EXTENDS BEYOND THE STICK. THIS PRODUCT WOULD BE BETTER DESIGNED IF THE SPONGE DID NOT EXTEND SO FAR PAST THE STICK. THE SPONGE ADHERES WELL TO THE STICK, BUT THE SPONGE THAT EXTENDS BEYOND THE STICK SHREADS/TEARS EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGE TOOTHETTE PLUS ORAL CARE SWAB/TOOTHETTE JOL SAGE PRODUCTS INC. * 04068/1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention