BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AH PLUS

    MDR report key: 681424 · Received March 2, 2006

    Report

    Report Number
    8010638-2006-00061
    Event Type
    Injury
    Date Received
    March 2, 2006
    Report Date
    January 31, 2006
    Manufacturer
    DENTSPLY DETREY-DEDENT
    Product Code
    KIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A PATIENT WITH KNOWN ALLERGIES TO CORTISONE AND PHENOLS DEVELOPED CARDIOVASCULAR SYMPTOMS AND A "SHIVERY FEELING" AFTER ENDODONTIC TREATMENT WITH AH PLUS ROOT CANAL SEALER. THERE IS NO INDICATIONS THAT MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO TREAT THE SYMPTOMS, THOUGH THE MATERIAL WAS MOST LIKELY REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AH PLUS ROOT CANAL SEALING MATERIAL KIF DENTSPLY DETREY-DEDENT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention