BEUDAMED
    FDA Adverse Event Other Summary report: N

    DASH

    MDR report key: 2872410 · Received November 9, 2012

    Report

    Report Number
    2032714-2012-00005
    Event Type
    Other
    Date Received
    November 9, 2012
    Date of Event
    May 1, 2012
    Report Date
    November 9, 2012
    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 PRODUCT RETAIN PASSED ALL MANUFACTURING SPECIFICATIONS, THE PERSONAL PHYSICIAN COULD NOT VERIFY THE PATIENTS SYMPTOMS WERE THE RESULT OF EXPOSURE TO THE DASH PROCEDURE AND NOT ALL ALLERGIC REACTIONS CAN BE PREDICTED ANY MAY VARY FROM PATIENT TO PATIENT.

    Description of Event or Problem · 1

    FEMALE PATIENT AFTER PROCEDURE SAID SHE HAD SINUS ISSUES, RUNNY NOSE AND MIGRAINE HEADACHES. PATIENT ADVISED HER PERSONAL PHYSICIAN. (B)(6) 2012, WHEN THIS EVENT WAS FIRST REPORTED TO THE DENTIST WAS WHEN THE PATIENT HAD A FOLLOW UP APPOINTMENT WITH HER PERSONAL PHYSICIAN; WHO COULD NOT VERIFY HER SYMPTOMS AS BEING THE RESULT OF THE DASH (NON-LIGHT ACTIVATED) CHAIR SIDE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH NON-LIGHT ACTIVATED CHAIRSIDE WHITENING GEX DISCUS DENTAL, LLC DSH1001 11276063

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other