MAUDE Adverse Event Report: GLUMA DESENSITIZER; DESENSITIZING AGENT

Catalog Number	65872354
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Caustic/Chemical Burns (2549)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's view: kulzer has evaluated based on the given information that the device has caused the injuries due to a wrong application procedure and a lack of protection measures.Kulzer reports this incident out of caution to be compliant with 21cfr 803 and out of abundance of caution.Nevertheless, the product was applied by a dental hygienist.In the ifu the user is defined as "gluma desensitizer should only be used by a dentist".Obviously the dental hygienist was either not aware, not trained or did not take care of ifu for the correct use of the product.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 described outcome.Unknown tablets were prescribed in connection with this incident.The patient did not come back to the dental clinic and kulzer does not have patient's contact data.Therefore, no update about the healing process could be verified.Nevertheless and according to kulzer's experience such minor injuries are self-healing and disappear usually 5 to 10 days after the burn's occurrence.
Event or Problem Description
A dental hygienist applied gluma desensitizer without protection of the gums by rubber dam.During the procedure the material dropped on the patient's gum.The patient complained about pain due to inflamed and bleeding gums.

• Brand Name: GLUMA DESENSITIZER
• Common Device Name: DESENSITIZING AGENT
• MDR Report Key: 10876680
• Report Number: 3005665377-2020-00007
• Device Sequence Number: 18251112
• Product Code: KLE
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 65872354
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/20/2020
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other