BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPURE MTAD

    MDR report key: 767275 · Received October 6, 2006

    Report

    Report Number
    2515379-2006-00419
    Event Type
    Injury
    Date Received
    October 6, 2006
    Date of Event
    September 6, 2006
    Report Date
    September 6, 2006
    Manufacturer
    DENTSPLY TULSA
    Product Code
    KJJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE ANTIBIOTICS WERE PRESCRIBED AND THE TOOTH WAS EXTRACTED TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AND SINCE 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, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. AS OF THIS REQUEST, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATED AND THE LOT NUMBER IS NOT AVAILABLE FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. IF THE LOT NUMBER IS PROVIDED, EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT BECAME RED, BEGAN TO SWELL, AND EXPERIENCED PAIN IMMEDIATELY AFTER BIOPURE MTAD WAS INADVERTENTLY DELIVERED INTO THE SOFT TISSUE VIA A PERFORATION IN THE ROOT, DURING ROOT CANAL TREATMENT. AS A RESULT, THE TOOTH WAS EXTRACTED AND ANTIBIOTICS (AUGMENTIN) WERE ADMINISTERED. ONE WEEK LATER, IT WAS NOTED THAT THE SWELLING WAS STILL PRESENT AND THE DOCTOR INDICATED AN INTENTION TO PRESCRIBE ANTI-INFLAMMATORY AND PAIN MEDICATIONS. THE DOCTOR ALSO PLANS ON RECOMMENDING THAT THE PATIENT BE TESTED FOR TETRACYCLINE SENSITIVITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention