BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGONIC FLEXDAM NON LATEX DENTAL DAM (PURPLE)

    MDR report key: 1481564 · Received September 11, 2009

    Report

    Report Number
    MW5012787
    Event Type
    Injury
    Date Received
    September 11, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 10, 2009
    Manufacturer
    COLTENE/WHALEDENT, INC
    Product Code
    EIE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER ALLERGIST (AS ALLERGIC REACTION PRECAUTION) PREDNISONE 20MG 2009 HS AND IN THE NEXT DAY. ROOT CANAL THERAPY AT ABOUT 4 DAYS PRIOR AT 9:30AM AND 5 DAYS AFTER. SLIGHT RASH AND BURNING ON FACE IMMEDIATELY WHEN DAM PLACED AND CONTACTED SKIN. QUESTIONED ENDODONTIST RE: MATERIAL OF DAM, ASSURED "NON-LATEX" SOME REDNESS AND ITCHING AND BURNING OF FACE WHEN LEFT OFFICE. BY 1:30 PM FULL REDNESS IN AREA WHERE DAM HAD BEEN PLACED, BURNING AND ITCHING ON FACE. RASPY VOICE, THROAT SWELLING, DIFFICULTY BREATHING, ASTHMA FLARE-UP. NOTIFIED ALLERGIST: PRESCRIBED PREDNISONE, BENADRYL, TOPICAL CORTISONE OINTMENT AND INCREASED INHALERS USE. REACTION STARTED TO DECREASE WITHIN 2 HOURS. COMPLETELY CLEARED BY AT ABOUT 5 DAYS LATER. NO RESIDUAL ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYGONIC FLEXDAM NON LATEX DENTAL DAM (PURPLE) DENTAL DAM EIE COLTENE/WHALEDENT, INC DO 9945

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention ROOT CANAL THERAPY