BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPURE MTAD

    MDR report key: 827640 · Received March 9, 2007

    Report

    Report Number
    2515379-2007-00065
    Event Type
    Injury
    Date Received
    March 9, 2007
    Date of Event
    February 5, 2007
    Report Date
    February 8, 2007
    Manufacturer
    DENTSPLY TULSA
    Product Code
    KJJ
    PMA / PMN Number
    K053167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE BIOPURE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. PLEASE NOTE THAT THE PT HAS REPORTEDLY MADE A FULL RECOVERY. A RETURNED SAMPLE WAS VISUALLY INSPECTED, EVALUATED FOR CHEMICAL PROPERTIES, AND FOUND TO BE IN SPEC. THE PRODUCT INVOLVED IN THE EVENT IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. FURTHER EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BIOPURE MTAD MATERIAL CONTACTED A PT'S LIP DURING AN ENDODONTIC PROCEDURE. THE PT IMMEDIATELY REPORTED A BURNING SENSATION AND THE LIP BEGAN TO SWELL. AS A RESULT, THE PT WAS SENT TO THE ER AND WAS ADMINISTERED FOUR SHOTS, TWO OF WHICH WERE BENADRYL AND PREDNISONE. THE NEXT MORNING, THE SWELLING REPORTEDLY HAD PROGRESSED TO THE RIGHT SIDE OF THE FACE PAST THE CENTER LINE AND UP TOWARD THE EYE. TWO DAYS FOLLOWING THE EVENT, THE PT RETURNED TO THE ER AND WAS ADMINISTERED IV AND ORAL ANTIBIOTICS IN ADDITION TO ORAL BENADRYL AND PREDNISONE; THE TREATING DR EXPRESSED SOME DOUBT OVER WHETHER THE SYMPTOMS WERE THE RESULT OF AN ALLERGIC REACTION DUE TO THE LACK OF RESPONSE TO THE TREATMENTS ADMINISTERED, THE SYMPTOMS REPORTEDLY IMPROVED FOLLOWING THE SECOND ER VISIT, THOUGH FOUR DAYS FOLLOWING THE INITIAL REACTION THE SYMPTOMS WERE REPORTED TO HAVE WORSENED. SEVERAL DAYS LATER, THE PT HAD THE TOOTH EXTRACTED DUE TO BUCCAL BONE LOSS (NO BUCCAL PLATE). THE INITIAL REPORTER STATED THAT THE ORAL SURGEON WAS "PRETTY CERTAIN THAT THE PT WAS AFFECTED BY SODIUM HYPOCHLORITE. IT WOULD HAVE ATTACKED THE LIP FIRST. THE PT SEEMS TO BE GETTING A BIT BETTER, BUT WITH ALL THE MEDICATIONS FOR ALLERGIC REACTIONS THAT THEY GAVE HIM, HE SHOULD HAVE GOTTEN BETTER PRETTY QUICKLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPURE MTAD KJJ KJJ DENTSPLY TULSA NA 060927

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SODIUM HYPOCHLORITE