BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKES RUBBER DAM CLAMP FORCEPS

    MDR report key: 11010988 · Received December 15, 2020

    Report

    Report Number
    8010168-2020-00002
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    October 7, 2020
    Report Date
    December 15, 2020
    Manufacturer
    GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
    Product Code
    EJG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO LOT NUMBER WAS PROVIDED FOR DHR REVIEW. REVIEW OF COMPLAINT HISTORY FOR 2018-2020 REVEALED THAT NO PREVIOUS COMPLAINTS HAVE BEEN RECEIVED FOR THIS DEVICE. PER THE PROVIDED IMAGE, THE FORCEPS ARE IN USED CONDITION WITH THE JAW TIPS BROKEN OFF DUE TO ROUGH HANDLING OR EXCESSIVE FORCE.

    Description of Event or Problem · 1

    THE RUBBER DAM CLAMP FORCEPS BROKE DURING A DENTAL PROCEDURE RESULTING IN A CHIPPED TOOTH NUMBER 24. THE PATIENT COMPLAINED OF PAIN AND DISCOMFORT AND THE TOOTH WAS REPAIRED WITH FILLING, CAUSING A 20-MINUTE DELAY IN TREATMENT. THE BROKEN PIECE OF THE FORCEPS WAS RETRIEVED. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476694 STOCKES RUBBER DAM CLAMP FORCEPS RUBBER DAM CLAMP FORCEPS EJG GEOMED MEDIZIN-TECHNIK GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other