EAGLE PLUGL 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 2013-11-12 for EAGLE PLUGL 3001 manufactured by Eaglevision, Inc..

Event Text Entries

[4013420] Physician reported patient with a granuloma like growth from the left lower punctum. The plug was removed and the patient was treated with tobradex drops.
Patient Sequence No: 1, Text Type: D, B5


[11267896] No additional information expected.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1034718-2013-00008
MDR Report Key3504247
Report Source05
Date Received2013-11-12
Date of Report2013-10-22
Date of Event2013-10-22
Date Mfgr Received2013-10-22
Device Manufacturer Date2012-12-01
Date Added to Maude2013-12-09
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 ContactMR. BILL GRAHAM, MANAGER
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 PLUGL
Generic NamePUNCTUM PLUG
Product CodeLZU
Date Received2013-11-12
Catalog Number3001
Lot Number77650
Device Expiration Date2017-12-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEAGLEVISION, INC.
Manufacturer AddressMEMPHIS TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-11-12

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