BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCEP RD

    MDR report key: 501348 · Received December 12, 2003

    Report

    Report Number
    1925223-2003-00001
    Event Type
    Injury
    Date Received
    December 12, 2003
    Report Date
    November 22, 2003
    Manufacturer
    HERAEUS KULZER, INC.
    Product Code
    EJG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RUBBER DAM FORCEPS BROKE DURING TREATMENT AND A PATIENT WAS HURT. AWAITING FURTHER DETAILS. DENTIST USES THE RUBBER DAM TECHNIQUE QUITE OFTEN AND SO HE BOUGHT SEVERAL FORCEPS OVER THE LAST YEARS. HE CAN'T REALLY TELL WHEN HE BOUGHT THE FORCEPS, WHICH BROKE NOW. AS FAR AS STERILIZATION IS CONCERNED THERE IS NOTHING UNUSUAL: HE USES A "THERMODISINFECTOR" AND FROM TIME TO TIME HE USES ALSO AN AUTOCLAVE. RECEIVED LETTER STATING THE FORCEPS FRACTURED WHEN PLACING A RUBBER DAM CLAMP ON TOOTH 47. THE RETURN SPRING CAUSED A MASSIVE FRACTURE IN THE DENTAL-LINGUAL PORTION OF A NEIGHBORING TOOTH (47). THE DAMAGED TOOTH WAS HEALTHY WITH THE EXCEPTION OF A SMALL OCCLUSAL FILLING. IT RESULTED IN THE TEMPORARY RESTORATION OF THE OPEN DENTIN WOUND WITH AN ADHESIVE COMPOSITE. ADEQUATE TREATMENT WITH POSSIBLE GRATED SUBSTANCE PRESERVATIONS, LIKELY REPLACEMENT WITH FULL CROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCEP RD 57220 EJG HERAEUS KULZER, INC. 50057220 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention