BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUMA DESENSITIZER POWERGEL

    MDR report key: 3857058 · Received June 9, 2014

    Report

    Report Number
    9610902-2014-00015
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 9, 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
    CA
    Reporter Occupation
    DENTIST

    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 DIRECTIONS FOR USE STATES, PROTECT MUCOUS MEMBRANES FROM CONTACT WITH THE PRODUCT USING A RUBBER DAM. THE DENTAL OFFICE 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 DESENSITIZER POWERGEL 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. CONCLUSION - 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. WARNINGS AND APPROPRIATE USAGE ARE CLEARLY STATED IN THE DIRECTIONS FOR USE. PRODUCT WAS DISPOSED OF BY OFFICE PRIOR TO CONTACTING THEM ABOUT THE RECALL.

    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. (B)(4). WARNINGS AND APPROPRIATE USAGE ARE CLEARLY STATED IN THE DIRECTIONS FOR USE. (B)(4). ON (B)(6) 2014 NARRATIVE: DEVICE EVALUATION FROM SAME LOT.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWELVE REPORTS FROM ONE OFFICE. NOTIFIED DENTIST OF RECALL VIA (B)(4) AND RECEIVED THE FOLLOWING RESPONSE: PLEASE KINDLY REPLACE THE ENTIRE LOTS AS SOON AS PRACTICABLE. THERE HAD BEEN PRIOR EXTENSIVE WASTAGE OF THE POWER GEL DUE TO IT BEING EXTRUDED FROM THE SYRINGES IN AN UNCONTROLLABLE MANNER. ON (B)(4) 2014, SPOKE TO THE DENTIST. HE SAID THAT ALL OF HIS SYRINGES HAVE EXPERIENCED THIS EXTRUSION ISSUE. HE SAID THAT AT LEAST 12 PATIENTS HAD THE MATERIAL EXTRUDE IN UNCONTROLLED MANNER INTO THEIR MOUTHS AND THAT HE RINSED IT OUT IMMEDIATELY. HE SAID THAT ONLY GINGIVAL IRRITATION WAS REPORTED FROM THE PATIENTS. HE DID NOT HAVE TIME TO LOOK UP THE PATIENTS INVOLVED AND DID NOT REMEMBER THEM OFF THE TOP OF HIS HEAD. HE DID NOT USE RUBBER DAM ISOLATION AND IT GOT ONTO THE PATIENT'S GINGIVA. HE SAID THAT THIS HAS OCCURRED IN (B)(6) OF THIS YEAR. HE NO LONGER HAS THE KITS AND STATED HE DID NOT UNDERSTAND WHY IT WOULD DO THIS UNTIL HE RECEIVED THE LETTER.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWELVE REPORTS FROM ONE OFFICE. NOTIFIED DENTIST OF RECALL VIA EMAIL AND RECEIVED THE FOLLOWING RESPONSE: PLEASE KINDLY REPLACE THE ENTIRE LOTS AS SOON AS PRACTICABLE. THERE HAD BEEN PRIOR EXTENSIVE WASTAGE OF THE POWER GEL DUE TO IT BEING EXTRUDED FROM THE SYRINGES IN AN UNCONTROLLABLE MANNER. ON (B)(6) 2014 SPOKE TO THE DENTIST. HE SAID THAT ALL OF HIS SYRINGES HAVE EXPERIENCED THIS EXTRUSION ISSUE. HE SAID THAT AT LEAST 12 PATIENTS HAD THE MATERIAL EXTRUDE IN UNCONTROLLED MANNER INTO THEIR MOUTHS AND THAT HE RINSED IT OUT IMMEDIATELY. HE SAID THAT ONLY GINGIVAL IRRITATION WAS REPORTED FROM THE PATIENTS. HE DID NOT HAVE TIME TO LOOK UP THE PATIENTS INVOLVED AND DID NOT REMEMBER THEM OFF THE TOP OF HIS HEAD. HE DID NOT USE RUBBER DAM ISOLATION AND IT GOT ONTO THE PATIENT'S GINGIVA. HE SAID THAT THIS HAS OCCURRED IN (B)(6) OF THIS YEAR. HE NO LONGER HAS THE KITS AND STATED HE DID NOT UNDERSTAND WHY IT WOULD DO THIS UNTIL HE RECEIVED THE LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334551 GLUMA DESENSITIZER POWERGEL VARNISH LBH HERAEUS KULZER GMBH 010103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention