BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUMA DESENSITIZER POWER GEL

    MDR report key: 3872121 · Received June 13, 2014

    Report

    Report Number
    9610902-2014-00027
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 14, 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
    AL, US
    Reporter Occupation
    DENTAL ASSISTANT

    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. METHOD/RESULTS/CONCLUSION: ACTUAL DEVICE HAS NOT BEEN RECEIVED BACK BY THE MANUFACTURER. 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 (B)(4) 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 TECHNIQUE IS NOT POSSIBLE. DEVICE NOT RETURNED.

    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. ACTUAL DEVICE HAS NOT BEEN RECEIVED BACK BY THE MANUFACTURER. 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 TECHNIQUE IS NOT POSSIBLE. SEPT. 09, 2014 DEVICE EVALUATION FROM SAME LOT. PLEASE SEE ATTACHED ROOT CAUSE REPORT AND CAPA REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT- (B)(6) FEMALE ALLEGES HARM-GINGIVA BURN. (B)(6) 2014 TISSUE RED BLISTERED AND BURNED STILL SYMPTOMATIC 6 WEEKS LATER. ASSISTANT CALLED BACK AFTER RECEIVING THE RECALL NOTIFICATION REGARDING SAID PRODUCT. SHE SAID THAT THIS OCCURRED IN THEIR OFFICE. SHE SAID THAT THEY HAD JUST RECEIVED THE PRODUCT AFTER ORDERING DURING A LUNCH AND LEARN WITH THE HERAEUS SALES REP. SHE SAID THAT THE FIRST TIME THE HYGIENIST USED IT, IT GOT ALL OVER THE UPPER LEFT SIDE OF THE PATIENTS MOUTH AND STARTED BURNING IMMEDIATELY. SHE WILL HAVE THE HYGIENIST CALL BACK TO GIVE TREATMENT DETAILS. SHE SAID THAT THE PATIENT CAME BACK THE NEXT MORNING WITH GINGIVAL BURN, BLISTERS AND REDNESS OF THE MUCOSA ON THE UPPER LEFT BUCCAL, LINGUAL, AND PALATE. THE HYGIENIST WAS TREATING THE PATIENT FOR CERVICAL SENSITIVITY ON THE UPPER LEFT PREMOLARS. SHE SAID THAT THE DENTIST PRESCRIBED MAGIC MOUTH MOUTHWASH WITH LIDOCAINE AND NORCO 10/325 FOR PAIN. SHE SAID IT HAS BEEN 6 WEEKS SINCE THIS OCCURRED AND THE PATIENT TISSUES ARE STILL SENSITIVE, WHITISH, WITH SOME SMALL BLISTERS REMAINING. THEY HAVE TOLD THE PATIENT IT SHOULD SLOUGH OFF EVENTUALLY. ADVISED OF THE DIRECTIONS REQUIRING THE USE OF A RUBBER DAM. SHE SAID THAT THE SALES REP DID NOT USE ONE OR ADVISE THEM TO USE ONE DURING THE LUNCH AND LEARN. SHE HAD TO GO BACK TO HER PATIENT BUT SAID THAT EITHER HER OR THE HYGIENIST WOULD CALL BACK LATER. 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.

    Description of Event or Problem · 1

    PATIENT-(B)(6) YRS. FEMALE ALLEGES HARM-GINGIVA BURN. (B)(6) 2014, TISSUE RED BLISTERED AND BURNED STILL SYMPTOMATIC 6 WEEKS LATER. ASSISTANT CALLED BACK AFTER RECEIVING THE RECALL NOTIFICATION REGARDING SAID PRODUCT. SHE SAID THAT THIS OCCURRED IN THEIR OFFICE. SHE SAID THAT THEY HAD JUST RECEIVED THE PRODUCT AFTER ORDERING DURING A LUNCH AND LEARN WITH THE HERAEUS SALES REP. SHE SAID THAT THE FIRST TIME THE HYGIENIST USED IT, IT GOT ALL OVER THE UPPER LEFT SIDE OF THE PATIENTS MOUTH AND STARTED BURNING IMMEDIATELY. SHE WILL HAVE THE HYGIENIST CALL BACK TO GIVE TREATMENT DETAILS. SHE SAID THAT THE PATIENT CAME BACK THE NEXT MORNING WITH GINGIVAL BURN, BLISTERS AND REDNESS OF THE MUCOSA ON THE UPPER LEFT BUCCAL, LINGUAL, AND PALATE. THE HYGIENIST WAS TREATING THE PATIENT FOR CERVICAL SENSITIVITY ON THE UPPER LEFT PREMOLARS. SHE SAID THAT THE DENTIST PRESCRIBED MAGIC MOUTH MOUTHWASH WITH LIDOCAINE AND NORCO 10/325 FOR PAIN. SHE SAID IT HAS BEEN 6 WEEKS SINCE THIS OCCURRED AND THE PATIENT TISSUES ARE STILL SENSITIVE, WHITISH, WITH SOME SMALL BLISTERS REMAINING. THEY HAVE TOLD THE PATIENT IT SHOULD SLOUGH OFF EVENTUALLY. ADVISED OF THE DIRECTIONS REQUIRING THE USE OF A RUBBER DAM. SHE SAID THAT THE SALES REP DID NOT USE ONE OR ADVISE THEM TO USE ONE DURING THE LUNCH AND LEARN. SHE HAD TO GO BACK TO HER PATIENT BUT SAID THAT EITHER HER OR THE HYGIENIST WOULD CALL BACK LATER. FDA-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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349594 GLUMA DESENSITIZER POWER GEL VARNISH,CAVITY LBH HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention