MAUDE Adverse Event Report: KULZER, GMBH-HQ GLUMA DESENSITIZER SINGLE DOSE 40 X 1 ST; AGENT, TOOTH BONDING, RESIN

Catalog Number 66001854

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Caustic/Chemical Burns (2549)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury: serious injury means an injury or illness that:(1) is life-threatening, (2) results in permanent impairment of a body function or permanent damage to a body structure, or (3) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The incident will be reported to maintain compliance with 21 cfr 803.This incident occurred due to user error, however permanent damage was caused and will need medical or surgical intervention to restore.Statement from the instructions for use: · protect mucous membranes by using a rubber dam.· remove moisture from the prepared dentine by applying a gentle stream of compressed air.· apply gluma desensitizer with a pellet and leave for 30-60 seconds.Make sure that only the smallest possible amount required is applied and that it only comes into contact with the area to be treated.· dry the dentinal surface carefully by applying a stream of compressed air, rinse off thoroughly with water and apply suction.· cover cavities and/or areas near the pulp with suitable cavity linings before applying the desensi.

Event Description

A dental hygiene student had gluma desensitizer applied by a fellow student while in class.The gluma was applied without a rubber dam which is recommended in the ifu.The only isolation used was cotton rolls.The gluma came in contact with her gingiva on teeth # 24 & #25 causing a chemical burn, pain, sensitivity, and loss of gingiva.She previously had 2mm of recession on these teeth and after the incident, # 25 now has 3mm of recession.She currently works at a dental office and was given palliative care instructions by a dentist in her office that consisted of warm saltwater rinses and possible gingival grafting.This incident occurred due to user error, however, the permanent damage that was caused and will need medical or surgical intervention to restore leads us to report this incident to the fda.

• Brand Name: GLUMA DESENSITIZER SINGLE DOSE 40 X 1 ST
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): KULZER, GMBH-HQ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 18874890
• MDR Text Key: 337323702
• Report Number: 1821514-2024-00001
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 66001854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/12/2024
• Event Location: Other
• Date Report to Manufacturer: 03/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female