BEUDAMED
    FDA Adverse Event Death Summary report: N

    ISODRY SYSTEM AND MOUTHPIECE

    MDR report key: 4168316 · Received September 19, 2014

    Report

    Report Number
    2032574-2014-00002
    Event Type
    Death
    Date Received
    September 19, 2014
    Date of Event
    April 15, 2014
    Report Date
    September 19, 2014
    Manufacturer
    INNERLITE SYSTEMS
    Product Code
    EIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR SAW THE PT IN (B)(6). HER APPOINTMENT WAS FOR CROWN PREP ON TWO TEETH (#14 AND 15 LEFT SIDE OF THE MOUTH). THE PT WAS DIAGNOSED AND TREATED FOR HEAD AND NECK CANCER IN 2008 (RIGHT SIDE OF THE MOUTH) AND HAD RADIATION TREATMENT. THE DOCTOR STATED HE SEATED THE PT AND PLACED A MOUTHPIECE AND BEGAN PREP OF THE FIRST TOOTH. HE WAS FINISHED WITHIN 30-40 MINUTES THEN HAD HER TAKE A BREAK WHILE HE PREPARED FOR THE SECOND PREP. SHE WAS ABLE TO GET UP AND MOVE AROUND, SAY HELLO TO STAFF MEMBERS, THEN AFTER 15-20 MINUTES CAME BACK TO THE CHAIR FOR FURTHER TREATMENT. HE WAS DONE WITH BOTH CROWN PREPS WITHIN 2 HOURS. THE DOCTOR WAS CONTACTED THE FOLLOWING TUESDAY AFTER THE APPOINTMENT. HE STATED HE WAS TOLD BY THE PT'S DAUGHTER THAT SHE HAD BEEN COMPLAINING OF SORE THROAT AND FEELING HOARSE AFTER HER DENTAL APPOINTMENT. PT WAS ALMOST (B)(6) AT THE TIME OF HER DEATH. ALTHOUGH SHE SEEMED TO BE DOING WELL, SHE HAD A LONG HISTORY OF CANCER AND HEART DISEASE (HAD A TRIPLE BYPASS). THE DEATH IS BEING ATTRIBUTED TO PNEUMONIA. THE PT WAS NEVER SEEN AT THE HOSPITAL, SHE DIED AT HOME IN HER BED. THE DOCTOR SAID THE FAMILY HAD THE PT CREMATED WITHIN TWO WEEKS AND NO AUTOPSY WAS COMPLETED.

    Description of Event or Problem · 1

    DOCTOR DID NOT REPORT THIS TO ISOLITE SYSTEMS UNTIL (B)(6) 2014 (5 MONTHS PAST EVENT) - (B)(6) FEMALE CANCER PT RECEIVED DENTAL CROWN PREPARATION/FILLINGS FROM DENTIST IN (B)(6) (USING AN ISODRY SYSTEM AND MOUTHPIECE). PT WAS TREATED WITHOUT INCIDENT. PT WENT HOME AND DIED THE FOLLOWING WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581366 ISODRY SYSTEM AND MOUTHPIECE ISODRY SYSTEM EIF INNERLITE SYSTEMS EID0101/CILXX01

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death