BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTRAX EPI 00

    MDR report key: 2796816 · Received October 12, 2012

    Report

    Report Number
    3011632-2012-00003
    Event Type
    Injury
    Date Received
    October 12, 2012
    Report Date
    October 11, 2012
    Manufacturer
    PASCAL CO., INC.
    Product Code
    EIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THIS IS A PRELIMINARY REPORT AWAITING MORE INFO FROM THE DENTIST. IT INVOLVES SIMILAR REACTIONS TO 3 PATIENTS OVER THE COURSE OF 12 MONTHS. THE DENTIST CONTACTED OUR OFFICE REQUESTING INFO ON OUR MEDICAL DEVICE, SILTRAX EPI 00, A GINGIVAL RETRACTION CORD CONTAINING EPINEPHRINE. THE ¿00¿ INDICATES THE SIZE OF THE CORD. DURING A PROCEDURE, WHERE THE DENTIST WAS ADMINISTERING SEVERAL PRODUCTS, INCLUDING SILTRAX EPI, THE PTS EXPERIENCED TISSUE AND BONE ¿SLOUGHING¿ (A TERM USED THE DENTIST). HE WAS NOT CLEAR AS TO THE EXTENT OF THE REACTION. BECAUSE THE DENTIST WAS USING A VARIETY OF PRODUCTS FROM A VARIETY OF MANUFACTURERS, HE WAS UNSURE WHICH ONE OR ONES CAUSED THIS REACTION. HE WAS CALLING THE MFRS OF ALL THE PRODUCTS HOPING TO GET SOME INSIGHTS. THE DENTIST SAID HE TOOK PICTURES AND WILL FORWARD THEM WHEN AVAILABLE. SOME OF THE PTS RECEIVED MEDICAL ATTENTION DAYS AFTER THE DENTAL PROCEDURE. THE COMMON THERAPY WAS ADMINISTRATION OF ANTIBIOTICS. THE DENTIST DID NOT SAY WHETHER THIS WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTRAX EPI 00 GINGIVAL RETRACTION CORD W/ EPINEPHRINE EIF PASCAL CO., INC. NA 090113

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention HEMODENT| ALUMINUM CHLORIDE TOPICAL SOLUTION