BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RC-2W AKA SARGENTI PASTE

    MDR report key: 746760 · Received July 18, 2006

    Report

    Report Number
    MW1039723
    Event Type
    Injury
    Date Received
    July 18, 2006
    Date of Event
    March 28, 2000
    Report Date
    July 18, 2006
    Manufacturer
    ELBEE CHEMISTIS INC.
    Product Code
    KIF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2000, A DENTIST HAD USED A SUBSTNACE CALLED SARGENTI PASTE AS A ROOT CANAL FILLER FOR MY TOOTH # 4 IN MY UPPER RIGHT JAW. SARGENTI PASTE CONTAINS PARAFORMALDEHYDE AND LEAD. IT HAS NEVER BEEN FDA APPROVED. IT HAS BEEN SEIZED BY THE FDA AND DISPOSED OF AS TOXIC WASTE. IT CAUSES MANY PROBLEMS WITH THE JAWBONE, AND THROUGHOUT THE BODY. ITS USE IS CONDEMNED BY DENTAL ORGANIZATIONS. SARGENTI PASTE MUMMIFIES THE BONE, AND DAMGES THE BLOOD VESSELS. I DEVELOPED OSTEOMYELITIS IN MY UPPER RIGHT JAW. THE DENTIST NEVER TOLD ME WHAT HE HAD USED OR HOW SERIOUS MY CONDITION WAS. I LOST FOUR TEETH, HAD TWO PICC LINES, DID HYPERBARIC OXYGEN AND HAD NUMEROUS SURGERIES. THE LAST SURGERY I HAD WAS A FIBULA FREE FLAP TRANSER. THEY TOOK BONE, BLOOD VESSELS, AND TISSUE OUT OF MY LEG AND REBUILT MY JAW. THIS IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RC-2W AKA SARGENTI PASTE * KIF ELBEE CHEMISTIS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L| O| R| S