BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 5783634 · Received July 11, 2016

    Report

    Report Number
    9610902-2016-00010
    Event Type
    Injury
    Date Received
    July 11, 2016
    Date of Event
    June 16, 2016
    Report Date
    June 16, 2016
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION# E2012008, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER GMBH (THE MANUFACTURER). THIS IS A SERIOUS INJURY (AS DEFINED IN 21 CFR SECTION 803.3) AS THE PATIENT REPORTED HAVING AN ADVERSE REACTION. BECAUSE THE MALFUNCTION ALLEGATION COULD NOT BE CONFIRMED, THE CAUSE OF THE ADVERSE REACTION COULD NOT BE DETERMINED. THIS INCIDENT IS BEING REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. DIRECTIONS FOR USE INDICATE RUBBER DAM USE IS REQUIRED. THE OFFICE DID NOT MAINTAIN ISOLATION. BY IMMEDIATELY RINSING PATIENT THE DENTAL ASSISTANT PREVENTED FURTHER TISSUE INJURY. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    DENTAL ASSISTANT USED GLUMA DESENSITIZER ON A FEMALE PATIENT AND DID NOT MAINTAIN ISOLATION. PATIENT COMPLAINED OF BURNING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437423 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH 65872354

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention