BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 5471500 · Received March 1, 2016

    Report

    Report Number
    9610902-2016-00007
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    November 18, 2015
    Report Date
    February 25, 2016
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    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 AND REQUIRED MEDICAL INTERVENTION TO PREVENT FURTHER INJURY. 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. NARRATIVE: DIRECTIONS FOR USE INDICATE RUBBER DAM USE IS REQUIRED.THE OFFICE USED ONLY GAUZE FOR ISOLATION, WHICH IS INADEQUATE. H3 OTHER TEXT : PRODUCT NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    (B)(6) FEMALE PATIENT REPORTING ADVERSE REACTION TO GLUMA DESENSITIZER. GLUMA DESENSITIZER PLACED (B)(6) 2015 AFTER GRAFTING SURGERY OF LOWER ANTERIOR HAD BEEN DONE ON (B)(6) 2015. PATIENT STATED GAUZE WAS USED INSIDE LOWER LIP, DOES NOT REMEMBER BEING RINSED. WAS TOLD NOT TO EAT OR DRINK FOR 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128025 GLUMA DESENSITIZER AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention