BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL FLOSS

    MDR report key: 2216968 · Received August 18, 2011

    Report

    Report Number
    MW5021781
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DENTAL FLOSS HAVE A BAD TASTE TO IT, AS IT'S MAKING HER FEEL NAUSEOUS. LEFT SIDE OF MOUTH HAS A BURNING SENSATION. TONGUE FEELS IRRITATED. DO NOT TRUST THE USE OF THIS FLOSS AS IT'S MADE IN (B)(6) AND WITH ALL THE RECALL COMING FROM THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTAL FLOSS JES SUNSTAR AMERICAS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR