BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVIEW SMALL KIT

    MDR report key: 6183616 · Received December 16, 2016

    Report

    Report Number
    8021023-2016-00002
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    January 1, 2016
    Report Date
    November 16, 2016
    Manufacturer
    KERR HAWE SA
    Product Code
    EIG
    PMA / PMN Number
    510K EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYMPTOMS WERE TREATED WITH BENTELAN. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION WAS CONDUCTED.

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF EVENT WAS NOT PROVIDED, THEREFORE THE INPUT OF (B)(6) 2016 IS THE BEST ESTIMATE OF WHEN THE EVENT OCCURED.

    Description of Event or Problem · 1

    A DENTIST INDICATED TWO (2) PATIENTS EXPERIENCED AN ALLERGIC REACTION RESULTING IN SWOLLEN LIPS, PAIN, AND ULCERS APPROXIMATELY TWO HOURS AFTER TREATMENT INVOLVING OPTIVIEW SMALL KIT. THIS IS THE FIRST OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834418 OPTIVIEW SMALL KIT LIP AND CHEEK RETRACTOR EIG KERR HAWE SA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R BLEACHING SOLUTION