MAUDE Adverse Event Report: KULZER, GMBH-HQ GLUMA DESENSITIZER; DESENSITIZING AGENT

Catalog Number 6603764

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 is reportable according to 21 cfr 803.The fda defines this as a serious injury (21 cfr sec.803.3) as the office staff reported gluma was accidentally dropped into the patients eye during application.It is stated in the instructions for use to wear protective goggles to prevent the material from splashing into the eyes.It also states that eyes should be rinsed immediately if this occurs.It is unknown if the patient sought medical intervention.It is also unknown if the patient had any complications or has healed.Due to this factor the incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.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: DESENSITIZING AGENT
• Manufacturer (Section D): KULZER, GMBH-HQ; leipziger strasse 2; hanau, hesse, 63450 ; GM 63450
• MDR Report Key: 11749323
• MDR Text Key: 248078828
• Report Number: 1821514-2021-00007
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6603764
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2021
• Event Location: Other
• Date Report to Manufacturer: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other