BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPURE MTAD

    MDR report key: 922727 · Received October 4, 2007

    Report

    Report Number
    2515379-2007-00172
    Event Type
    Injury
    Date Received
    October 4, 2007
    Date of Event
    September 11, 2007
    Report Date
    September 11, 2007
    Manufacturer
    DENTSPLY TULSA
    Product Code
    KJJ
    PMA / PMN Number
    K053167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE BIOPURE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'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. THE DEVICE WAS RETURNED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECAME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED SWELLING AND POST-OPERATIVE PAIN IN THE AREA OF A TOOTH IN WHICH BIOPURE MTAD WAS USED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION PERTAINING TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPURE MTAD KJJ DENTSPLY TULSA NA 060616

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other