MAUDE Adverse Event Report: KULZER GMBH GLUMA DESENSITIZER

Model 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); Local Reaction (2035); Burning Sensation (2146); Discomfort (2330); Caustic/Chemical Burns (2549)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

The patient herself contacted kulzer (b)(4) (manufacturer) via our e-mail hotline: (b)(4).The global safety manager was informed the same day and informed the next day kulzer (b)(4) with all given contact data.(b)(4) contacted the patient and evaluated the following information: patient was seen at dental office for a dental procedure.Doctor applied gluma desensitizer intraorally.During gluma application the liquid material accidentally got in patient's 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; the 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 burnings.Subsequent follow up with patient confirmed she is 100% healed and asymptomatic.This desensitizing liquid is known to be caustic to soft tissue.This could be avoided by ifu recommended measures, as we state there the necessity to use safety goggles and rubber dam to protect soft tissue and eyes.In this case neither were utilized per the patient's given information.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 desensitizer liquid was used and accidently got in patient's eye.Patient suffered burned mucosa in mouth, too.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: DESENSITIZER
• Manufacturer (Section D): KULZER GMBH; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• Manufacturer (Section G): KULZER GMBH - WEHRHEIM SITE; philipp-reis-strasse 8/13; wehrheim, hesse 61273 ; GM 61273
• Manufacturer Contact: albert erdrich ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 8822218
• MDR Text Key: 152062884
• Report Number: 9610902-2019-00009
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 65872354
• Device Catalogue Number: 65872354
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other