BEUDAMED
    FDA Adverse Event Other Summary report: N

    DENTAL DAM 5 X 5 LIGHT MED READY CUT DAM

    MDR report key: 2586470 · Received April 4, 2012

    Report

    Report Number
    2416455-2012-00002
    Event Type
    Other
    Date Received
    April 4, 2012
    Date of Event
    February 23, 2012
    Report Date
    April 3, 2012
    Manufacturer
    COLTENE/WHALEDENT INC.
    Product Code
    EEF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF THIS SINGLE-USE DEVICE WAS REPROCESSED AND REUSED ON A PT. THE DENTAL OFFICE WAS CONTACTED TO GATHER ADD'L INFO BUT THE INFO PROVIDED BY THE DENTAL OFFICE DID NOT INCLUDE INFO IN REGARDS TO REPROCESSED OR REUSED DEVICES. DUE TO THE NATURE OF THIS TYPE OF DEVICE IT IS HIGHLY UNLIKELY TO BE REPROCESSED OR REUSED. IT IS IMPOSSIBLE TO DETERMINE THE EXACT NATURE OF THE ALLERGIC REACTION. AS NOTED IN THE ORIGINAL COMPLAINT THE DENTAL OFFICE ALSO USED LATEX GLOVES SO THE ALLERGIC REACTION COULD HAVE BEEN CAUSED BY EITHER THE LATEX GLOVES OR THE DENTAL DAM OR THE COMBINATION OF USING BOTH. ALLERGIC REACTIONS TO THE USE OF LATEX PRODUCTS IS WELL KNOWN IN THE DENTAL INDUSTRY AND THE PRODUCT IS LABELED WITH CAUTION STATEMENTS TELLING THE END USER THE PRODUCT CONTAINS NATURAL RUBBER WHICH MAY CAUSE ALLERGIC REACTIONS. THE LABELING WAS VERIFIED AS BEING CORRECT IN ITS APPLICATION AND VERBIAGE AS SPECIFIED IN 21 CFR 801.437 USER LABELING FOR DEVICES THAT CONTAIN NATURAL RUBBER.

    Description of Event or Problem · 1

    OFFICE SAYS THEY HAVE HAD 2 OF THEIR PTS WITH BLISTERING AND SWELLING ON THEIR LIPS CAUSED BY THE DENTAL DAMS. BUT THEY ALSO USE LATEX GLOVES. THE DENTAL OFFICE REPORTS THAT BOTH PTS WERE HEALTHY AND NORMAL CONDITION BEFORE THE EVENT. THE DENTAL OFFICE REPORTS THE CONDITION OF BOTH PTS AFTER THE EVENT AS HAVING BLISTERS AND SWELLING ON THE LIPS. THE DENTAL OFFICE REPORTS WHEN THE (B)(6) CAME BACK TO THE OFFICE THREE DAYS AFTER THE EVENT FOR A F/U THERE WERE STILL INDICATIONS OF BLISTERING ON HER BOTTOM LIP AND THAT MEDICAL TREATMENT WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTAL DAM 5 X 5 LIGHT MED READY CUT DAM EIE - RUBBER DAM EEF COLTENE/WHALEDENT INC. 036F3

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other