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 report with the FDA on 2013-10-30 for EAGLE PLUG1 3001 manufactured by Eagle Vision, Inc..

Event Text Entries

[3847814] Physician reported the pt developed a pyrogenic granuloma in the punctum of the lower lid. The plug was explanted and the pt was treated with lotemax twice a day then 1 time a day for 2 weeks.
Patient Sequence No: 1, Text Type: D, B5


[11245889] The pt's granuloma has been resolved with treatment.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1034718-2013-00006
MDR Report Key3449648
Report Source05
Date Received2013-10-30
Date of Report2013-10-03
Date of Event2012-11-28
Date Mfgr Received2013-10-03
Device Manufacturer Date2012-05-01
Date Added to Maude2013-11-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHYSICIAN ASSISTANT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR. BILL GRAHAM, MGR
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 Received2013-10-30
Catalog Number3001
Lot Number77308
Device Expiration Date2017-05-31
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. Required No Informationntervention 2013-10-30

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