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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KULZER GMBH GLUMA DESENSITIZER; DESENSITIZING AGENT
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KULZER GMBH GLUMA DESENSITIZER; DESENSITIZING AGENT Back to Search Results
Catalog Number 65872354
Device Problem Use of Device Problem (1670)
Patient Problems Local Reaction (2035); Burning Sensation (2146); Discomfort (2330); Caustic/Chemical Burns (2549)
Event Date 03/26/2019
Event Type  Injury  
Manufacturer Narrative
Obviously the dentist was not aware or did not take care of ifu for the correct use of the product.He only speaks about some warnings in the small print.The ifu clearly recommends for the application of the product sufficient soft tissue protection, the use of a minimal amount of the product.Additionally it clearly says: after application rinse off thoroughly after 30 to 60 s residence time with suction of the flush.If too much material is used or residues of the desensitizing chemicals in gluma desensitizer stay on the tooth and get in contact to mucosa, this will exactly lead to the outcome the dentist's report described.No analysis of the product was done due to the fact that no product was returned.It made no sense to analyze retained samples because the dentist very obviously did not follow the instructions for use: the product was nearly 3 years expired due to the given batch information; very probably and according to the dentist's own information, used without sufficient protection of soft tissue; very probably and according to the dentist's own information, used excessively against the recommendation for use.Kulzer (b)(4) has evaluated based on the given information of the patient that the device has caused the injuries due to a wrong application procedure and a lack of protection measures.Kulzer (b)(4) reports this incident out of caution to be compliant with 21cfr 803 and out of abundance of caution.(b)(4).
 
Event Description
Patient experienced severe immediate sensitivity of soft tissues adjacent to site, where material was applied, and subsequent burning.The patient was taking gluma desensitising agent by kulzer for: dentinal hypersensitivity.Due to the dentists report: the patient completely recovered.The burning issue resolved.
 
Manufacturer Narrative
After further internal review this event should not have been reported.There was not medical intervention nor any serious injury per fda definitions.We have had to report to uk-mhra due to the fact that we were asked by nca for report, despite the aforementioned evaluation of the event.Additionally we inadvertently checked box h7 "notification" which was a mistake in understanding the intention of h7 (if remedial action initiated) on our part and should not have been selected.Kulzer initiated no remedial action due to this event.- attachment: [reportoverview-gb-mhra-eyc00197804_24195_yc.Pdf].
 
Event Description
Patient experienced severe immediate sensitivity of soft tissues adjacent to site, where material was applied, and subsequent burning.The patient was taking gluma desensitising agent by kulzer for: dentinal hypersensitivity.Due to the dentists report: the patient completely recovered.The burning issue resolved.
 
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Brand Name
GLUMA DESENSITIZER
Type of Device
DESENSITIZING AGENT
Manufacturer (Section D)
KULZER GMBH
leipziger strasse 2
hanau, hesse 63450
GM  63450
MDR Report Key8752900
MDR Text Key149783927
Report Number9610902-2019-00008
Device Sequence Number1
Product Code KLE
Combination Product (y/n)N
PMA/PMN Number
K962812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Remedial Action Notification
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/10/2016
Device Catalogue Number65872354
Device Lot Number010210
Was Device Available for Evaluation? No
Date Manufacturer Received06/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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