BEUDAMED
    FDA Adverse Event Other Summary report: N

    DASH

    MDR report key: 2389896 · Received November 8, 2011

    Report

    Report Number
    2032714-2011-00010
    Event Type
    Other
    Date Received
    November 8, 2011
    Date of Event
    October 24, 2011
    Report Date
    November 7, 2011
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAIN SAMPLE WITH THE SAME LOT NUMBER WAS TESTED AND FOUND TO BE WITHIN MFG SPECIFICATIONS. THE WORK ORDER HISTORY OF THE GEL WAS FOUND TO BE APPROPRIATE AND CORRECTLY RECONCILED.

    Description of Event or Problem · 1

    FEMALE PT WENT TO SEE HER PRIMARY DOCTOR BECAUSE 1 - 2 DAYS AFTER THE NON LIGHT ACTIVATED CHAIR SIDE PROCEDURE (DASH), HER LIPS BECAME SWOLLEN. THE DENTIST, DR. (B)(6) ADVISED THAT WHEN SHE LEFT THE DENTAL OFFICE SHE DID NOT SHOW SIGNS OF HER LIPS SWELLING NOR OF ANY BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH GEX DISCUS DENTAL, LLC DSH1001 11136072

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other