MAUDE Adverse Event Report: KULZER GMBH - HQ GLUMA DESENSITIZER

Model Number 65872354

Device Problem Use of Device Problem (1670)

Patient Problems Eye Injury (1845); Pain (1994); Local Reaction (2035); Discomfort (2330)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

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 solely the result of user error with no other performance issue, and there has been no device-related death or serious injury, you are not required to submit an mdr report." serious injury means an injury or illness that: is life-threatening, results in permanent impairment of a body function or permanent damage to a body structure, or 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 very likely cause permanent damage.This will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

Event Description

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 takin 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.New information from dental surgery on (b)(6) 2019: the symptoms have healed.The patient had seen multiple dr.'s including an eye doctor, prescribed one medication and one over the counter medication.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: DESENSITIZER
• Manufacturer (Section D): KULZER GMBH - HQ; leipziger strasse 2; hanau, 63450 ; GM 63450
• Manufacturer (Section G): KULZER GMBH - KDEW; philipp-reis-strasse 8/13; wehrheim, 61273 ; GM 61273
• Manufacturer Contact: albert erdrich ; leipziger strasse 2; hanau, 63450 ; GM 63450
• MDR Report Key: 9502434
• MDR Text Key: 188544555
• Report Number: 9610902-2019-00012
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 65872354
• Device Catalogue Number: 65872354
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other