BEUDAMED
    FDA Adverse Event Other Summary report: N

    DENTAL DAM

    MDR report key: 119480 · Received September 11, 1997

    Report

    Report Number
    2416455-1997-00002
    Event Type
    Other
    Date Received
    September 11, 1997
    Date of Event
    July 17, 1997
    Manufacturer
    COLTENE/WHALEDENT INC
    Product Code
    EIE
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD TO BE RUSHED TO HOSPITAL 45 MINUTES AFTER RECEIVING AN INJECTION OF LIDOCAINE WITH RUBBER DAM IN PLACE WAS RECEIVED ON SEPTEMBER 1997. SOURCE DID NOT ACTUALLY SPEAK TO DR BUT TO SOMEONE IN HIS OFFICE. SOURCE TOLD ME THAT PT WAS OK, AND THAT SOURCE DID NOT KNOW THE CONCENTRATION OF THE LIDOCAINE INJECTION. (AT THIS POINT THERE WAS NO CLEAR CUT INDICATION AS TO WHAT CAUSED A REACTION.) THIS WAS THE FIRST TIME DR TREATED THIS PT. DR MENTIONED THAT PT HAD RECEIVED PRIOR DENTAL TREATMENT BUT NOT BY HIM AND HE DID NOT KNOW BY WHOM. PT WAS UNAWARE OF ANY ALLERGIES. DR TOLD CO THAT AFTER PLACING THE RUBBER DAM AND INJECTING WITH 2% PT EXHIBITED FACIAL SWELLING AND BREATHING DIFFICULTIES AND WAS RUSHED TO HOSPITAL. DATE OF OCCURRENCE WAS 7/17/97. ACCORDING TO DR, PT DID NOT GO INTO ANAPHYLACTIC SHOCK AND WAS OK SOON THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTAL DAM ISOLATION/BARRIER PRODUCT EIE COLTENE/WHALEDENT INC MEDIUM GREEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA