SMART PLUG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-25 for SMART PLUG manufactured by Medennium.

Event Text Entries

[18570854] I had medennium smart plugs inserted into both my lower canaliculi in 2003. One came out in my nose within a year. I assumed the other hand had eventually flushed through; though this was never verified. In (b)(6) 2013, i experienced complete blockage of my nld and have had chronic canaliculitis, epiphora, discharge, pain and photophobia for the 10 months since then. Oculoplastic surgeon concurs that it is due to a migrated smartplug. Canaliculotomy in (b)(6) 2014 failed to locate the plug. Will proceed to external dcr.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038411
MDR Report Key4135454
Date Received2014-09-25
Date of Report2014-09-25
Date Added to Maude2014-10-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSMART PLUG
Generic NameSMART PLUG
Product CodeLZU
Date Received2014-09-25
Device Sequence No1
Device Event Key0
ManufacturerMEDENNIUM


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2014-09-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.