BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AH PLUS

    MDR report key: 3131301 · Received May 15, 2013

    Report

    Report Number
    8010638-2013-00004
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 16, 2013
    Manufacturer
    DENTSPLY DETREY GMBH
    Product Code
    KIF
    PMA / PMN Number
    K960548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE DEVICE 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. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PT WITH SEVERAL KNOWN ALLERGIES EXPERIENCED AN ALLERGIC REACTION APPROX 3 HOURS AFTER USE OF AH PLUS DURING A DENTAL PROCEDURE. THE REPORTED SYMPTOMS WERE SWELLING OF THE PT'S CHEEKS, LIP AND EYES; RED EYES; AND TINGLING. THE PT WAS TREATED WITH DELTACORTENE CPR .25MG AND RUPAFIN CPR 10MG, AS A RESULT OF THE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216199 AH PLUS KIF DENTSPLY DETREY GMBH 1301000834

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANESTHESIA: CITOCARTIN