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

Catalog Number	66001854
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pain (1994); Caustic/Chemical Burns (2549)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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.Udi related data quality updates only no udi-pi/ batch number has been provided to kulzer by complainant despite several attempts.
Event or Problem 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
• Common Device Name: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): KULZER GMBH - HQ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• Manufacturer (Section G): KULZER GMBH - WEHRHEIM; philipp-reis-strasse 8/13; wehrheim, hesse 61273 ; GM 61273
• Manufacturer Contact: matthias hartmann ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 18884012
• Report Number: 3005665377-2024-00001
• Device Sequence Number: 7539562
• Product Code: KLE
• UDI-Device Identifier: J014660018540
• UDI-Public: +J014660018540
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: Other
• Device Catalogue Number: 66001854
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 10/31/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female