MAUDE Adverse Event Report: KULZER, GMBH GLUMA DESENSITIZER

Catalog Number 65872354

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Pain (1994); Burning Sensation (2146)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Kulzer north america was notified of this incident by global safety manager at kulzer (b)(4) (manufacturer).Patient was seen at dental office for dental procedure.Doctor applied gluma intraorally.During gluma application material accidentally got in patients eye through splatter.Doctor had patient flush eye immediately with water for approximately 20-30 minutes.Patient was wearing contacts which she removed half way through flushing.Patient called ophthalmologist prior to departing dental office.Ophthalmologist instructed patient to use artificial tears every hour for 24 hours.Patient followed up next day with ophthalmologist, office was confident there were not injuries caused to the eye due to the patient being asymptomatic and experiencing no vision changes.Due to the immediate attention needed for gluma contact in the eye, gluma was left in the mouth the entire time causing burning.Subsequent follow up with patient confirmed she is 100% healed and asymptomatic.This material is known to be caustic to soft tissue.This is mitigated in our ifu as we state that safety goggles and the use of rubber dam to protect soft tissues and eyes.In this case neither were utilized per patient.This will be reported to maintain compliance with 21 cfr part 803 as if this were to recur, it could very likely cause permanent eye damage.Also being reported out of an abundance of caution.

Event Description

Patient was seen for dental procedure.Gluma was used and accidently got in eye.Also suffered burned mucosa in mouth.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: DESENSITIZER
• Manufacturer (Section D): KULZER, GMBH; philipp-reis-strabe 8/13; wehrheim, D-612 73; GM D-61273
• MDR Report Key: 8793617
• MDR Text Key: 151132131
• Report Number: 1821514-2019-00009
• 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
• Type of Report: Initial
• Report Date: 07/01/2019,07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 65872354
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Event Location: Other
• Date Report to Manufacturer: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other