BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 4062841 · Received September 5, 2014

    Report

    Report Number
    9610902-2014-00044
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 14, 2014
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION# (B)(4), HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MANUFACTURER).ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION.(B)(4). DEVICE HAS NOT BEEN RETURNED TO THE IMPORTER.

    Description of Event or Problem · 1

    REPORTED TO HERAEUS KULZER (B)(4) ON (B)(6) 2014 BY: (B)(6). ON (B)(6); 5 DAYS AFTER THE APPLICATION THE PATIENT HAD NUMBNESS ON HER GUM. TREATMENT TETRACYCLINE OINTMENT AND STEROID OINTMENT AFTER THE TREATMENT ON (B)(6), SYMPTOMS WERE IMPROVED SOON. REMARKS A SUBSTITUTE DENTIST APPLIED GLUMA TO THE PATIENT. RINSING WAS NOT ENOUGH. THIS INCIDENT OCCURRED IN (B)(6). THIS IS A SERIOUS INJURY (AS DEFINED IN 21 CFR SECTION 803.3) AND REQUIRES INTERVENTION TO PREVENT POTENTIAL PERMANENT HARM TO A BODY STRUCTURE. THIS INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546451 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention