BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA COMFORT BOND AND DESENSITIZER

    MDR report key: 3342415 · Received May 6, 2013

    Report

    Report Number
    1925223-2013-00061
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THIS IS THE FIFTH OF FIVE REPORTS FOR ONE DEVICE. ON (B)(6) 2013 A DEALER REPRESENTATIVE CALLED AND SAID THAT A DENTIST HAS PATIENT THAT ARE SENSITIVE AFTER USE OF GCB AND D. SPOKE TO THE DENTIST. SHE SAID SHE HAS BEEN HAVING TROUBLE WITH THE GCB AND D LEAVING HER PATIENTS SENSITIVE AND REQUIRING REPLACEMENT OF FILLINGS. I ASKED HER TO DESCRIBE TREATMENT TECHNIQUE. SHE SAID SHE ETCHES, RINSES, GENTLY AIR DRIES, THEN APPLIES THE GCB AND D THEN RUBS A FEW SECONDS THEN CURES. SHE SAID SHE DOES THIS THREE TIMES BEING SURE TO CURE BETWEEN EACH LAYER. DISCUSSED THE TECHNIQUE VARIATIONS FROM THOSE IN THE DFU. I ASKED HOW MANY PATIENTS SHE HAD TO REPLACE. SHE SAID SHE HAD 5 PATIENTS THAT REQUIRED REPLACEMENT. I ASKED IF SHE COULD PULL THE CHARTS ON THE PATIENTS AND GIVE INCIDENT DATES. SHE SAID SHE DID NOT HAVE TIME FOR THIS. SEVERAL FOLLOW UP CALLS HAVE BEEN MADE TO THE OFFICE WITHOUT RESPONSE BACK. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198150 GLUMA COMFORT BOND AND DESENSITIZER KLE AGENT, TOOTH BONDING RESIN KLE HERAEUS KULZER GMBH 010209

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention