BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTRAGATE

    MDR report key: 1870101 · Received September 30, 2010

    Report

    Report Number
    9612352-2010-00002
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 28, 2010
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EIG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE IT IS UNCLEAR WHETHER NUMBNESS IS PERMANENT, MANUFACTURER HAS CHOSEN TO REPORT AS ADVERSE INCIDENT.

    Description of Event or Problem · 1

    DENTIST DESCRIBES THAT HE USED AN OPTRAGATE TO ISOLATE AN ADULT TO PLACE A BONDED RETAINER FROM #22-27. THE PT CALLED BACK THE NEXT DAY TO REPORT THAT HER LIPS, CHIN AND NOSE WERE NUMB. NO ANESTHETIC WAS USED. DENTIST REPORTS NUMBNESS HAS CONTINUED FOR 2 WEEKS AS OF DATE OF THIS REPORT AND PT BELIEVES IS SPREADING NOW TO HER NOSE AND CHEEKS. THE PT IS A (B)(6) FEMALE WITH POSSIBLE LATEX ALLERGY. NITRILE EXAM GLOVES WERE USED. THE OPTRAGATE DOES NOT CONTAIN LATEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTRAGATE CHEEK RETRACTOR EIG IVOCLAR VIVADENT AG ML5508

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability