BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRYZ

    MDR report key: 3675351 · Received March 7, 2014

    Report

    Report Number
    MW5034893
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    PARKELL
    Product Code
    MVL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A BURNING SENSATION DIRECTLY AFTER PRODUCT WAS APPLIED. DIAGNOSIS OR REASON FOR USE: TEMPORARY RETRACTION AND HEMOSTASIS OF THE GINGIVAL MARGIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139518 DRYZ DRYZ MVL PARKELL * 13309

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR