BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AH PLUS

    MDR report key: 1951892 · Received December 31, 2010

    Report

    Report Number
    8010638-2010-00121
    Event Type
    Injury
    Date Received
    December 31, 2010
    Report Date
    December 3, 2010
    Manufacturer
    DENTSPLY DETREY
    Product Code
    KIF
    PMA / PMN Number
    K960548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION THAT THE AH PLUS USED MALFUNCTIONED, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY BECAUSE OF THE POSSIBILITY THAT PERMANENT IMPAIRMENT OF A BODY FUNCTION RESULTED.

    Description of Event or Problem · 1

    IN THIS EVENT, A DOCTOR REPORTED THAT DURING AN ENDODONTIC PROCEDURE ON A PATIENT, HE PASSED THROUGH THE APEX AND A SMALL QUANTITY OF AH PLUS REACHED THE DENTARIO NERVE; SINCE THIS INCIDENT THE PT HAS EXPERIENCED PARESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AH PLUS KIF DENTSPLY DETREY 1006000477

    Patients

    Seq Age Sex Outcome Treatment
    1 Other