BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V3 RING UNIVERSAL

    MDR report key: 6472663 · Received April 7, 2017

    Report

    Report Number
    3003959465-2017-00001
    Event Type
    Injury
    Date Received
    April 7, 2017
    Report Date
    April 7, 2017
    Manufacturer
    DENTSPLY (N.Z.) LIMITED
    Product Code
    DZN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A V3 TRIODENT UNIVERSAL RING WAS SWALLOWED BY A PATIENT DURING A DENTAL PROCEDURE. THE CLINICIAN DID NOT USE A RUBBER DAM AS RECOMMENDED PER THE IFU. THE PATIENT WAS SENT TO A GI SPECIALIST WHO RETRIEVED THE RING WITH AN ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255956 V3 RING UNIVERSAL INSTRUMENTS, DENTAL HAND DZN DENTSPLY (N.Z.) LIMITED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention