MAUDE Adverse Event Report: KULZER GMBH - HQ GLUMA DESENSITIZER; AGENT, TOOTH BONDING, RESIN

Catalog Number 66003764

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem Eye Injury (1845)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

This incident occurred in (b)(6).

Event Description

A droplet of gluma desensitizer was accidentally dropped into patients eye.This incident occurred in (b)(6).

• Brand Name: GLUMA DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): KULZER GMBH - HQ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 11783269
• MDR Text Key: 249322189
• Report Number: 3005665377-2021-00006
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• PMA/PMN Number: K962812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66003764
• Date Manufacturer Received: 04/07/2021
• 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