COLLEGEN EYE PLUGS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-16 for COLLEGEN EYE PLUGS manufactured by Unk.

Event Text Entries

[68019665] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5067972
MDR Report Key6345651
Date Received2017-02-16
Date of Report2017-02-16
Date of Event2016-12-28
Date Added to Maude2017-02-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCOLLEGEN EYE PLUGS
Generic NamePLUG, PUNCTUM
Product CodeLZU
Date Received2017-02-16
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-02-16

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