BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUTTA PERCHA

    MDR report key: 362498 · Received November 20, 2001

    Report

    Report Number
    MW1023480
    Event Type
    Other
    Date Received
    November 20, 2001
    Report Date
    November 20, 2001
    Manufacturer
    *
    Product Code
    EKM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD A ROOT CANAL WITH GUTTA PERCHA (LATEX) FILLING. THIS WAS MANY YEARS AGO. THE ROOT HAS NOW SPLIT, AND THE LATEX FILLING IS EXPOSED. RPTR DOES NOT KNOW HOW LONG IT HAS BEEN LIKE THAT. RPTR IS GETTING IRRITATION AND REACTIONS AND THINKS THE LATEX IS THE PROBLEM. RPTR HAS ASKED THEIR DENTIST TO REMOVE THE LATEX, PROBABLY BY INCISION THROUGH THE GUM, AS THE LATEX IS LOOSE AND EXPOSED BUT HE IS RESISTING. HE WILL REMOVE THE WHOLE TOOTH, WHICH RPTR DOES NOT WANT TO DO AS RPTR SEES NO REASON TO DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52539 GUTTA PERCHA * EKM * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other