BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 3314030 · Received August 20, 2013

    Report

    Report Number
    9610902-2013-00082
    Event Type
    Injury
    Date Received
    August 20, 2013
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS (B)(4) (THE MFR). 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. CONCLUSIONS:THE DIRECTIONS FOR USE STATES, "PROTECT MUCOUS MEMBRANES BY USING A RUBBER DAM. MAKE SURE THAT GLUMA DESENSITIZER ONLY COMES INTO CONTACT WITH THE AREA TO BE TREATED." THE PT REPORTED THAT A RUBBER DAM WAS NOT USED. SHE DESCRIBED THE USE OF DRY ANGLES. DRY ANGLES ARE NOT PROPER ISOLATION OF TISSUE; THEREFORE, THE USER WOULD HAVE EXPOSED THE SOFT TISSUES TO THE GLUMA DESENSITIZER. IT IS ADDRESSED IN THE DIRECTIONS FOR USE THAT GLUMA DESENSITIZER IS IRRITATING TO SKIN AND CONTACT WITH SKIN SHOULD BE AVOIDED. THE DIRECTIONS ALSO STATE, "GLUMA DESENSITIZER MUST NOT BE USED IF THE PT IS ALLERGIC TO ANY INGREDIENTS CONTAINED IN GLUMA DESENSITIZER." THE DIRECTIONS FOR USE ALSO STATES THAT GLUMA DESENSITIZER IS, "HARMFUL, (B)(4). IRRITATING TO SKIN. MAY CAUSE SENSITIZATION BY SKIN CONTACT." THE DIRECTIONS FOR USE ALSO STATES THAT IF NECESSARY PRECAUTIONS CANNOT BE TAKEN THEN GLUMA DESENSITIZER MUST NOT BE USED. ADDITIONAL NARRATIVE: THE LABELING GIVES SUFFICIENT WARNING TO THE USER. THE USER REPORTEDLY DID NOT PROTECT THE PT AS DIRECTED IN THE DIRECTIONS FOR USE. DUE TO THE AFOREMENTIONED REASON, CAPA MEASURES ARE NOT RECOMMENDED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404172 GLUMA DESENSITIZER KLE TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1