BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPS CONTRAST SPRAY CHAIRSIDE 50ML

    MDR report key: 2394900 · Received November 28, 2011

    Report

    Report Number
    9612352-2011-00008
    Event Type
    Injury
    Date Received
    November 28, 2011
    Date of Event
    October 20, 2011
    Report Date
    November 23, 2011
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    NOF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS INVESTIGATED AND CLINICIAN INDICATED THAT THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS WHEN SHE LEFT THE OFFICE AND APPEARED TO BE FINE. SHE NEVER REPORTED THAT SHE HAD ASTHMA DURING HER MEDICAL EXAM. PATIENT WAS HEAVY SET THAT ALSO MIGHT CAUSE DIFFICULTIES BREATHING. PATIENT IS REPORTED TO HAVE FULLY RECOVERED. THE PRODUCT MSDS INCLUDES INFORMATION REGARDING THE CONTENTS AS WELL AS RESPIRATORY PRECAUTIONS.

    Description of Event or Problem · 1

    PATIENT CLAIMS SHE EXPERIENCED A MAJOR ASTHMATIC ATTACK AFTER TREATMENT WITH CONTRAST SPRAY CHAIRSIDE AND REQUIRED A TRIP TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPS CONTRAST SPRAY CHAIRSIDE 50ML ACCESSORY TO OPTICAL IMPRESSION SYSTEM NOF IVOCLAR VIVADENT AG 614435AN ML8503

    Patients

    Seq Age Sex Outcome Treatment
    1 Other