*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-12 for * manufactured by *.

Event Text Entries

[394989] The pt had glaucoma of both eyes in 2003 diagnosed as pseudo exfoliative glaucoma. Corneal tissue was transplanted. Pt has been put on eye drops but she is now blind in the right eye and can barely see with the left eye as well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1037649
MDR Report Key666270
Date Received2005-01-12
Date of Report2005-01-12
Date of Event2003-02-27
Date Added to Maude2006-01-24
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 FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameCORNEAL TISSUE
Product CodeLMO
Date Received2005-01-12
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key655645
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2005-01-12

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