BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACTIVATOR PLUS PASTE 60 ML (DEVICE 1)

    MDR report key: 2682721 · Received July 26, 2012

    Report

    Report Number
    9681707-2011-00007
    Event Type
    Other
    Date Received
    July 26, 2012
    Report Date
    June 28, 2012
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    ELW
    PMA / PMN Number
    K080338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION# (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS (B)(4) (THE MFR). ALTHOUGH WE HAVE NOT ESTABLISHED THT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF CAUTION TO BE COMPLIANT WITH 21 CFR PART 803. WE CANNOT RULE OUT CAUSALITY. CONCLUSION CODE - THE DIRECTIONS FOR USE STATE, "DO NOT SWALLOW AND INGEST. IF HEALTH PROBLEMS ARISE AFTER SWALLOWING IMPRESSION MATERIAL, SEEK MEDICAL ATTENTION IMMEDIATELY. INTESTINAL BLOCKAGE MAY ARISE IN RARE CASES."

    Description of Event or Problem · 1

    THIS IS THE SECOND OF 2 DEVICES INVOLVED IN THE INCIDENT. ON (B)(6) 2012, DENTIST IN (B)(6)REPORTED TO HERAEUS (B)(4) THAT A PT SWALLOWED IMPRESSION MATERIAL DURING AN UPPER FUNCTIONAL IMPRESSION WITH XANTOPREN COMFORT AND THE OLD PROSTHESIS USED AS A TRAY. A SMALL AMOUNT OF THE CURED EXCESS IMPRESSION MATERIAL ON THE PALATE HAS BEEN SWALLOWED. THE DENTIST WAS CONCERNED THAT THE SWALLOWED MATERIAL COULD HAVE CHEMICALLY TOXICOLOGICAL CONSEQUENCES IN THE GASTRO INTESTINAL TRACT AND THEREFORE, HE CALLED US. HE HAS ALSO CONSULTED A LOCAL MEDICAL COLLEAGUE ABOUT WHAT COULD HAPPEN. THE MEDICAL COLLEAGUE HAS POINTED OUT THAT IT MAY BE A POTENTIAL INTESTINAL OBSTRUCTION OR MECHANICALLY CATCHING IN DIVERTICULUM IN THE INTESTINES WHICH CAN COME WITH SUBSEQUENT COMPLICATION SUCH AS INTESTINAL OBSTRUCTION AND / OR INTESTINAL PERFORATION. AN IMMEDIATE SURGERY SUCH AS GASTRIC OR COLONOSCOPY, THE DOCTOR HAS ALSO DISCOURAGED BECAUSE THE MATERIAL CAN PASS THE INTESTINE COMPLETELY HARMLESS. THE HKG REP CONFIRMED THAT THERE ARE NO TOXICOLOGICAL RISKS, BECAUSE THE MATERIAL DOES NOT DISSOLVE OR CHEMICALLY MODIFIED AND AGREED THAT MEDICAL INTERVENTION IN THE SITUATION ALSO NOT ADVISABLE. THE DENTIST WILL INFORM THE PT ABOUT THE RISKS AND ADVISE THAT HE MONITOR FOR STOMACH PROBLEMS OVER THE NEXT 3-4 WEEKS. SHOULD THE PT HAVE ANY STOMACH PROBLEM, HE SHOULD ADVISE THE DENTIST AND IMMEDIATELY GO TO THE HOSPITAL. ON (B)(6) 2012, THE DENTIST SPOKE TO THE PT. THE PT REPORTED NO PECULIARITY WHEN EATING OR DIGESTING: EVERYTHING IS PERFECTLY NORMAL. PT WAS AGAIN WARNED OF POSSIBLE SYMPTOMS AS THE PT DID NOT REPORT PASSING THE IMPRESSION MATERIAL. ON (B)(6) 2012, THE PT WAS STILL DOING WELL AND THERE WERE NO ABNORMALITIES. DENTIST SPOKE YESTERDAY ON THE PHONE WITH THE PT AND WILL CALL NEXT WEEK AGAIN. ON (B)(6) 2012, (B)(4) SPOKE TO THE DENTIST CONCERNING THIS CASE. HE CONFIRMED THAT HE HAD A PHONE CALL WITH THE PT TODAY: THE PT IS FINE AND IS SHOWING NO SIGN OF STOMACH DISCOMFORT WHICH WOULD GIVE ANY INDICATION OF A PROBLEM WITH THE SWALLOWED IMPRESSION MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVATOR PLUS PASTE 60 ML (DEVICE 1) ELW IMPRESSION MATERIAL ELW HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other