BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUBBER DAM CLAMP FORCEP

    MDR report key: 10852069 · Received November 17, 2020

    Report

    Report Number
    2523190-2020-00142
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 13, 2020
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EJG
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    A DUPLICATE REPORT WAS SUBMITTED FOR THIS COMPLAINT EVENT UNDER MFG REPORT NUMBER 2523190-2020-00126. CONSEQUENTLY, NO INVESTIGATION RESULTS WILL BE SUBMITTED FOR THIS EVENT, AS ALL INFORMATION WAS PREVIOUSLY SUBMITTED UNDER MFG REPORT NUMBER 2523190-2020-00126.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A DENTAL FACILITY REPORTED THAT DURING USE ON A PATIENT, THE RIGHT TIP OF THE MILTEX RUBBER DAM CLAMP FORCEPS BROKE OFF. ADDITIONAL INFORMATION FROM FACILITY CLARIFIED THE FORCEPS CHIPPED TOOTH NUMBER 24 INCISAL LINGUAL EDGE WHILE HOLDING THE RUBBER DAM IN PLACE. THIS BROUGHT THE PATIENT TO TEARS AND THE DENTIST HAD TO FIX THE CHIPPED TOOTH. THE PROCEDURE WAS DELAYED BY 20 MINUTES DUE TO THE CHIPPED TOOTH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317374 RUBBER DAM CLAMP FORCEP M51 - GENERAL DENTISTRY EJG INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1