BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOND TOTAL ETCH

    MDR report key: 6385672 · Received March 7, 2017

    Report

    Report Number
    9610902-2017-00003
    Event Type
    Injury
    Date Received
    March 7, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 17, 2017
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    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 WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. AS ALLOWED BY EXEMPTION# E2012008, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER GMBH (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. DIRECTIONS FOR USE INDICATE AVOID CONTACT WITH SOFT TISSUE. ISOLATION FAILED TO BE MAINTAINED BY THE CLINICIAN. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 0

    IBOND TOTAL ETCH DRIPPED ON PATIENTS LIPS AND CAUSED A WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166162 IBOND TOTAL ETCH AGENT, TOOTH BONDING, RESIN KLE HERAEUS KULZER GMBH 010507

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention