BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SDI SUPER ETCHJ JUMBO 37%

    MDR report key: 17720070 · Received September 8, 2023

    Report

    Report Number
    MW5145457
    Event Type
    Injury
    Date Received
    September 8, 2023
    Report Date
    September 5, 2023
    Manufacturer
    SDI LIMITED
    Product Code
    EBF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    RESELLER, DARBY DENTAL SUPPLY LLC RECEIVED REPORT FROM DR (B)(6), PHONE (B)(6) THAT PRODUCT SUPER ETCH (JUMBO) WAS USED ON PATIENT, (B)(6). PATIENT COMPLAINED OF BURNING SENSATION IN THE CHEEKS AND TOOTH. SDI INC. CONTACTED THE SURGERY PLACE ON (B)(6) FOR MORE DETAILS AND WAS INFORMED THAT THE PATIENT WAS AN ASSISTANT WORKING AT THIS SURGERY PLACE. OFFICE DECLINED TO PROVIDE MORE DETAILS DUE TO CONFIDENTIALITY AND SUGGESTED TO CALL AGAIN TO SPEAK TO OFFICE MANAGER. SDI SPOKE TO THE OFFICE AGAIN THE NEXT DAY AND WAS TOLD IT WAS AGAINST THEIR POLICY TO DISCLOSE PATIENT'S INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061942 SDI SUPER ETCHJ JUMBO 37% MATERIAL, TOOTH SHADE, RESIN EBF SDI LIMITED 220601

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown