EAGLE PLUG1 3001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-19 for EAGLE PLUG1 3001 manufactured by Eagle Vision, Inc..

Event Text Entries

[3290918] Patient returned for follow-up visit with punctum plug protruding, superiorly, from the punctum of the left eye. There was a tissue growth around the punctum plug. Plug was removed and treated with antibiotic drops and reported in good condition.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1034718-2013-00001
MDR Report Key3083991
Report Source05,06
Date Received2013-04-19
Date of Report2013-03-21
Date of Event2013-01-08
Date Mfgr Received2013-03-21
Date Added to Maude2013-05-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street8500 WOLF LAKE DR. SUITE 110
Manufacturer CityMEMPHIS TN 38133
Manufacturer CountryUS
Manufacturer Postal38133
Manufacturer Phone9013807000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEAGLE PLUG1
Generic NamePUNCTUM PLUG
Product CodeLZU
Date Received2013-04-19
Catalog Number3001
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEAGLE VISION, INC.
Manufacturer AddressMEMPHIS TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-04-19

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