MAUDE Adverse Event Report: KULZER, GMBH GLUMA DESENSITIZER; DESENSITIZER, PRODUCT CODE: KLE

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 12/02/2019

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019- kulzer rep received a phone call from a dental assistant asking for msds information for gluma.She told her they had a patient that got gluma in her eye.Rep asked for the info and i informed her that i will need to contact the office as this is an allegation of harm.She gave me the office information.The same day i called the office and spoke to the assistant.The female patient was seen on (b)(6) 2019.During the treatment, the assistant passed the dr.A microbrush with gluma on the tip and some of the gluma fell into the patients eye.The patient was immediately rushed to the eye wash sink where they flushed her eye for a few minutes.Then the patient used her own eye drops once taken back to the operatory room.The patient on her own accord went to the emergency room today.The office was contacted by the nurse at the er to gather information on the product used.The patient has pain in her eye and it is very red.The patient was not wearing protective eye goggles during the treatment.I sent the office through email the msds sheet for gluma desensitizer per their request.I explained to the office, under certain circumstances, that we are required to report incidences to the fda when our products cause harm, she understood.Also let her know i will contact them next week to check on the status of the patient.On (b)(6) 2019- left message for assistant to call me back.On (b)(6) 2019- left message for assistant to call me back.On (b)(6) 2019- received call back from the dental assistant.The patient was present during the phone call.The first thing the assistant asked was is the patient could be reimbursed from kulzer for her medical bills stemming from the gluma in her eye.I explained that in the instructions for use it is stated safety goggles/eye wear is needed and that this material is caustic to soft tissue and the use of a rubber dam is also needed.Explained that we would not be covering any expenses the patient incurred due to the product not being used correctly.The assistant asked if we had reported the incident yet, i explained we have 30 days to report to the fda and that every reportable event can found on their website.I asked if the patient had healed, she said she has.The patient had seen multiple dr.'s including an eye doctor, prescribed one medication and one over the counter medication.Names of the prescriptions undisclosed.I asked if either of them had any other questions for me, she stated no.Gave my information and let her know if she had any other questions to contact me.According to the medical device reporting for manufacturers guidance for industry and food and drug administration staff issued on november 8, 2016 section 2.6 of this guidance referring to 21 cfr 803 states, "if you determine that an event is soley the result of user error with no other performance issue, and there has been no device related death or serious injury, you ar not required to submit an mdr report." 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.This incident is reportable despite the fact of user error, no safety goggles were utilized which is recommended in the dfu.The patient sought secondary care and was prescribed medication, medical intervention to prevent permanent damage.If this was to re-occur, it could likely cause permanent damage.This will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

Event Description

Gluma dropped into patient's eye during treatment.No safety goggles worn.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: DESENSITIZER, PRODUCT CODE: KLE
• Manufacturer (Section D): KULZER, GMBH; philipp-reis-strabe 8/13; wehrheim, D-612 73; GM D-61273
• MDR Report Key: 9495081
• MDR Text Key: 188489573
• Report Number: 1821514-2019-00013
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2019,12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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: 12/02/2019
• Event Location: Other
• Date Report to Manufacturer: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other