BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KETAC CEM RADIOPAQUE

    MDR report key: 90643 · Received May 12, 1997

    Report

    Report Number
    9611385-1997-90001
    Event Type
    Injury
    Date Received
    May 12, 1997
    Date of Event
    April 25, 1997
    Report Date
    April 30, 1997
    Manufacturer
    ESPE GMBH & CO. KG.
    Product Code
    EMA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 75 YEAR OLD PT INITIALLY REPORTED SENSITIVITY PROBLEMS ON MARCH 24, 1997 WITH CROWNS HE HAD PLACED IN HIS MOUTH ON FEB 11 WITH KETAC-CEM. PT CLAIMED THAT HE EXPERIENCED SENSITIVITY IMMEDIATELY AFTER THE PROCEDURE AND THAT IT HAS NOT SUBSIDED THOUGH IT HAS BEEN OVER A MONTH. DR. INDICATED THAT HE DID NOT BELIEVE THEY WERE DUE TO THE CEMENT. THE DOCTOR SAID THAT THE DISCOMFORT PT WAS EXPERIENCING WAS DUE TO EXTREMES IN TEMPERATURES FOR EXAMPLE AFFECTED BY HOT AND COLD FOODS AND DRINKS. DR REFERRED PT TO ENDODONTIST WHO DETERMINGED THAT A ROOT CANAL WAS NOT NECESSARY AND SUGGESTED THAT THE PT USE A DESENSITIZING TOOTHPASTE TO COUNTERACT THE SENSITIVITY. SINCE THE INCIDENT WAS NOT LIFE THREATENING, IT DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR STRUCTURE AND DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT, CO INITIALLY DID NOT CONSIDER IT AS MDR REPORTABLE. ON APRIL 25, 1997 CO LEARNED THAT PT'S SENSITIVITY/DISCOMFORT HAD NOT SUBSIDED AND THAT DR REMOVED THE CROWNS. CO FOLLOWED UP DR WHO CONFIRMED THAT HE DID REMOVE THE CROWNS BECAUSE OF THE PT COMPLAINING OF DISCOMFORT, HOWEVER, DR REITERATED THAT HE DID NOT THINK THE SYMPTOM WAS DUE TO THE CEMENT. BECAUSE THERE WAS NOT IMMEDIATE RELIEF AFTER THE REMOVAL OF THE CROWNS. CO BELIEVES THAT PT'S PROBLEM COULD NOT HAVE BEEN CAUSED BY CO'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KETAC CEM RADIOPAQUE Implant GLASS IONOMER CEMENT EMA ESPE GMBH & CO. KG. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization WERE USED ON THE PT.| LATEX GLOVES, RETRACTION FLUID AND IMPRESSION WERE