BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISTA DENTAL PRODUCTS / SYRINGE SODIUM HYPOCHLORITE

    MDR report key: 8636605 · Received May 22, 2019

    Report

    Report Number
    MW5086860
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    May 8, 2019
    Report Date
    May 17, 2019
    Manufacturer
    INTER - MED, INC.
    Product Code
    KJJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VISTA DENTAL PRODUCTS - SODIUM HYPOCHLORITE SYRINGE; UPON PREPARING TO IRRIGATE DURING A ROOT CANAL, IT WAS DISCOVERED THAT THE SYRINGE WHEN TESTED PRIOR TO IRRIGATING, SPILLED A YELLOWISH FLUID FOLLOWED BY BLACK FLUID. BLACK FLUID WAS EXPELLED WHEN TESTING OTHER SYRINGES. THIS WAS SEEN ONCE PREVIOUSLY BUT THE STAFF THOUGHT IT WAS A FLUKE AND DIDN'T SEE IT AGAIN UNTIL (B)(6) 2019. VISTA DENTAL PRODUCTS, (B)(6) US. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423870 VISTA DENTAL PRODUCTS / SYRINGE SODIUM HYPOCHLORITE CLEANSER, ROOT CANAL KJJ INTER - MED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1