BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGENIC NON-LATEX FLEXI-DAM

    MDR report key: 4423292 · Received January 12, 2015

    Report

    Report Number
    2416455-2015-00001
    Event Type
    Injury
    Date Received
    January 12, 2015
    Date of Event
    November 6, 2014
    Report Date
    January 7, 2015
    Manufacturer
    COLTENE/WHALEDENT INC.
    Product Code
    EIE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PATIENT LEFT THE OFFICE AND THEN CALLED THE OFFICE 20 MINUTES LATER TO REPORT THE PATIENT HAD HIVES OVER HIS BODY AND WOULD START TAKING BENADRYL FOR THE REACTION. PHONE MESSAGES WERE LEFT FOR THE PATIENT AT 10:30AM AND ALSO AT 1:00PM. PATIENT RETURNED PROVIDES CALL TO INDICATE "THE ITCHY SENSATION STARTED WHEN THE PURPLE THING WAS PLACED IN MY MOUTH". CONFIRMED WITH THE PATIENT THAT NON-LATEX ITEMS WERE UTILIZED FOR THE PATIENT AND THE PATIENT WAS THE FIRST AND ONLY PATIENT IN THE #10 OPERATORY FOR THE DAY. THE PATIENT INDICATED THERE WAS NO FURTHER INCREASE OF SYMPTOMS ONCE THE ANTIBIOTIC MATERIAL WAS INTRODUCED INTO THE CANALS. PATIENT WAS FEELING BETTER WITH THE DOSE OF BENADRYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27656 HYGENIC NON-LATEX FLEXI-DAM DENTAL DAM EIE COLTENE/WHALEDENT INC. NA 140G

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other ZINC PHOSPATE| MINOCYCLINE AND METRONIDAZOLE PASTE| LATEX-FREE GLOVES| CP| CAVIT| CIPROFLOXACIN