BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER POWER GEL

    MDR report key: 3884913 · Received June 19, 2014

    Report

    Report Number
    9610902-2014-00035
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 21, 2014
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Removal / Correction Number
    1925223-04/23/14-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER. EVALUATION OF MALFUNCTION ROOT CAUSE IN PROGRESS. LABELING EVALUATION- THE DIRECTIONS STATES, "PROTECT MUCOUS MEMBRANES FROM CONTACT WITH THE PRODUCT USING A RUBBER DAM." STAFF REPORTED THAT ONLY COTTON ROLL ISOLATION METHOD WAS USED. WITHOUT PROPER ISOLATION THE USER EXPOSED THE SOFT TISSUES TO THE GLUMA DESENSITIZER. " THE DIRECTIONS ALSO STATES, GLUMA DPG MUST NOT BE USED IF THE NECESSARY PRECAUTIONS CANNOT BE TAKEN OR THE STIPULATED APPLICATION TECHNIQUE IS NOT POSSIBLE. IT ALSO STATES, ONLY TO BE USED BY DENTIST. THE DIRECTION FOR USE HAS ADEQUATE WARNING AGAINST EXPOSURE STATING, "IRRITATING TO SKIN. THE PRODUCT CONTAINS METHACRYLATE COMPOUNDS THAT MAY CAUSE SENSITIZATION BY SKIN CONTACT. GLUMA DESENSITIZER POWERGEL CONTAINS GLUTARDIALDEHYDE THAT MAY CAUSE LOCALIZED IRRITATION AND MAY CAUSE SENSITIZATION EITHER DIRECTLY OR THROUGH INHALATION. AVOID CONTACT WITH SKIN, IMMEDIATELY WASH WITH PLENTY OF WATER AND SOAP. THE DIRECTIONS ALSO STATES, "GLUMA DPG MUST NOT BE USED IF THE NECESSARY PRECAUTIONS CANNOT BE TAKEN OR THE STIPULATED APPLICATION. DEVICE EVALUATION FROM SAME LOT. PLEASE SEE ATTACHED ROOT CAUSE REPORT AND CAPA REPORT. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    AS ALLOWED BY EXEMPTION # (B)(4) , (B)(4) (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) -THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER. EVALUATION OF MALFUNCTION ROOT CAUSE IN PROGRESS. THE DIRECTIONS STATES, "PROTECT MUCOUS MEMBRANES FROM CONTACT WITH THE PRODUCT USING A RUBBER DAM." STAFF REPORTED THAT ONLY COTTON ROLL ISOLATION METHOD WAS USED. WITHOUT PROPER ISOLATION THE USER EXPOSED THE SOFT TISSUES TO THE GLUMA DESENSITIZER." THE DIRECTIONS ALSO STATES, GLUMA DPG MUST NOT BE USED IF THE NECESSARY PRECAUTIONS CANNOT BE TAKEN OR THE STIPULATED APPLICATION TECHNIQUE IS NOT POSSIBLE. IT ALSO STATES, ONLY TO BE USED BY DENTIST. THE DIRECTION FOR USE HAS ADEQUATE WARNING AGAINST EXPOSURE STATING, "IRRITATING TO SKIN. THE PRODUCT CONTAINS METHACRYLATE COMPOUNDS THAT MAY CAUSE SENSITIZATION BY SKIN CONTACT. GLUMA DESENSITIZER POWERGEL CONTAINS GLUTARDIALDEHYDE THAT MAY CAUSE LOCALIZED IRRITATION AND MAY CAUSE SENSITIZATION EITHER DIRECTLY OR THROUGH INHALATION. AVOID CONTACT WITH SKIN, IMMEDIATELY WASH WITH PLENTY OF WATER AND SOAP. THE DIRECTIONS ALSO STATES, "GLUMA DPG MUST NOT BE USED IF THE NECESSARY PRECAUTIONS CANNOT BE TAKEN OR THE STIPULATED APPLICATION. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    ASSISTANT CALLED AFTER RECEIVING THE RECALL LETTER. SHE SAID SHE HAD EXPERIENCED THE ISSUE TWICE. PATIENT-FEMALE, (B)(6). HYGIENIST STATED THAT SHE WAS TREATING CHRONIC SENSITIVITY ON A PATIENT WITH RECESSION ON #23-26. SHE SAID SHE EXTRUDED THE MATERIAL AND IT BLOBBED OUT. SHE SAID IT WAS ON THE TISSUE ABOUT 6 SECONDS. AND THE PATIENT FELT IT BURNING. SHE SAID SHE RINSED IT OFF AND THE PATIENT CALLED HER A FEW HOURS LATER BECAUSE HER GUMS WERE PEELING OFF. SHE SAID SHE HAD JUST SEEN THE PATIENT THIS WEEK FOR HER THREE MONTH RECALL. SHE SAID THAT THE TISSUE HAD RETURNED TO NORMAL WITH NO ADDITIONAL RECESSION. THIS IS A REPORTABLE MALFUNCTION ACCORDING TO 21 CFR 803.50 (A) (2) WHICH STATES THAT YOU MUST REPORT TO US NO LATER THAN 30 CALENDAR DAYS AFTER THE DAY THAT YOU RECEIVE OR OTHERWISE BECOME AWARE OF INFORMATION, FROM ANY SOURCE, THAT REASONABLY SUGGESTS THAT A DEVICE THAT YOU MARKET HAS MALFUNCTIONED AND THIS DEVICE OR A SIMILAR DEVICE THAT YOU MARKET WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. THIS IS A REPORTABLE MALFUNCTION AS THIS MALFUNCTION COULD CAUSE SERIOUS INJURY IF THE MATERIAL SHOOTS INTO THE PATIENT'S MOUTH OR OTHER AREAS OF THE BODY TO WHICH IT IS NOT INTENDED. ALSO THIS MATERIAL BATCH IS BEING RECALLED DUE TO THIS ISSUE.

    Description of Event or Problem · 1

    ASSISTANT CALLED AFTER RECEIVING THE RECALL LETTER. SHE SAID SHE HAD EXPERIENCED THE ISSUE TWICE. PATIENT-FEMALE, (B)(6). HYGIENIST STATED THAT SHE WAS TREATING CHRONIC SENSITIVITY ON A PATIENT WITH RECESSION ON #23-26. SHE SAID SHE EXTRUDED THE MATERIAL AND IT BLOBBED OUT. SHE SAID IT WAS ON THE TISSUE ABOUT 6 SECONDS. AND THE PATIENT FELT IT BURNING. SHE SAID SHE RINSED IT OFF AND THE PATIENT CALLED HER A FEW HOURS LATER BECAUSE HER GUMS WERE PEELING OFF. SHE SAID SHE JUST SEEN THE PATIENT THIS WEEK FOR HER THREE MONTH RECALL. SHE SAID THAT THE TISSUE HAD RETURNED TO NORMAL WITH NO ADDITIONAL RECESSION. THIS IS A REPORTABLE MALFUNCTION ACCORDING TO 21 CFR 803.50 (A) (2) WHICH STATES THAT YOU MUST REPORT TO US NO LATER THAN 30 CALENDAR DAYS AFTER THE DAY THAT YOU RECEIVE OR OTHERWISE BECOME AWARE OF INFORMATION, FROM ANY SOURCE, THAT REASONABLY SUGGESTS THAT A DEVICE THAT YOU MARKET HAS MALFUNCTIONED AND THIS DEVICE OR A SIMILAR DEVICE THAT YOU MARKET WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. THIS IS A REPORTABLE MALFUNCTION AS THIS MALFUNCTION COULD CAUSE SERIOUS INJURY IF THE MATERIAL SHOOTS INTO THE PATIENT'S MOUTH OR OTHER AREAS OF THE BODY TO WHICH IT IS NOT INTENDED. ALSO THIS MATERIAL BATCH IS BEING RECALLED DUE TO THIS ISS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360091 GLUMA DESENSITIZER POWER GEL VARNISH, CAVITY LBH HERAEUS KULZER GMBH 010103

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention