MAUDE Adverse Event Report: COLLEGEN EYE PLUGS; PLUG, PUNCTUM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Pain (1994)

Event Date 12/28/2016

Event Type  Injury  

Event Description

Had eye plugs put into eyes for relief of dry eyes.Was told they were made of collagen.Told they would dissolve into body after 7 days.Shortly after this time, 8/9 days later was experiencing pain above a tooth in gum which radiated down through a healthy tooth.Was strange to me because i go to the dentist every 3 months.No problems with teeth prior to placement of these plugs.Went to dentist, told by dentist on call (not my regular dentist, that i had an abscess.Would probably need root canal or extraction.I was a dental assistant years ago.I did not agree with the finds of dentist on call.I felt definitely had some infection, but it was not from the tooth.Went on antibiotic, had xray, and two days later, saw my regular dentist.My dentist told me "the tooth was healthy" infection was not from the tooth.It was located in the gum.There was no reason for this other than from the placement of the dissolving eye plugs.I could have been subjected to a very expensive procedure, root canal, or tooth extraction because of an infection.I truly believe was caused by these collagen plugs.I was lucky i had knowledge from being a dental assistant in the past, to realize abscess develope for reasons that were not present in me prior to the placement of these eye plugs.

• Brand Name: COLLEGEN EYE PLUGS
• Type of Device: PLUG, PUNCTUM
• MDR Report Key: 6345651
• MDR Text Key: 68019665
• Report Number: MW5067972
• Device Sequence Number: 1
• Product Code: LZU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 84