BEUDAMED
    FDA Adverse Event Other Summary report: N

    YANKAUER BULB RIGID W/O TROL

    MDR report key: 3177585 · Received June 14, 2013

    Report

    Report Number
    9612030-2013-00018
    Event Type
    Other
    Date Received
    June 14, 2013
    Report Date
    May 20, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A YANKAUER. THE CUSTOMER REPORTS THAT A PT WAS CUT BY THE TIP OF THE PRODUCT IN THE BACK OF THE MOUTH. THE CUSTOMER ALSO REPORTS THAT THE CUT CAUSED BLEEDING. THE YANKAUER WAS SHARP ALONG THE VERTICAL EDGE, HOWEVER, AFTER MULTIPLE PEOPLE FELT THE SHARP EDGE, THE SHARP EDGE WENT AWAY. THERE WAS NO ADDITIONAL INJURY TO THE PT AND NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271987 YANKAUER BULB RIGID W/O TROL YANKAUER JOL COVIDIEN 8888505016 207325664X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK