BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    NITROSPRAY PLUS

    MDR report key: 11761062 · Received May 3, 2021

    Report

    Report Number
    2511556-2020-00002
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    December 1, 2020
    Report Date
    December 2, 2020
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Product Code
    GEH
    UDI-DI
    D6911006060
    PMA / PMN Number
    K970992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INTERVIEW WITH THE OFFICE, IT WAS DISCLOSED THAT A SPRAY TIP WAS NOT APPLIED TO THE NITROSPRAY PLUS NOZZLE. THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED. SUBMITTING REPORT AGAIN TO CORRECT THE ERROR OF SUMMARY REPORT BOX BEING CHECKED.

    Description of Event or Problem · 0

    DUE TO USER ERROR, TWO PATIENTS HAD BLISTERING AFTER TREATMENT. PATIENTS WERE MONITORED FOR HEALING, BOTH BURNS WERE NOT SERIOUS AND DID NOT REQUIRE MEDICAL TREATMENT.

    Additional Manufacturer Narrative · 1

    DURING THE INTERVIEW WITH THE OFFICE, IT WAS DISCLOSED THAT A SPRAY TIP WAS NOT APPLIED TO THE NITROSPRAY PLUS NOZZLE. THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED. ORIGINAL MFR REPORT NUMBER 2511556-2020-00001 WAS FILED.

    Description of Event or Problem · 1

    DUE TO USER ERROR, TWO PATIENTS HAD BLISTERING AFTER TREATMENT. PATIENTS WERE MONITORED FOR HEALING, BOTH BURNS WERE NOT SERIOUS AND DID NOT REQUIRE MEDICAL TREATMENT. THIS IS THE MDR REPORT FOR THE 2ND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657319 NITROSPRAY PLUS CRYOSURGICAL UNIT GEH PREMIER DENTAL PRODUCTS CO. 1006060 14623 D6911006060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other