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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 Number: MW1037649
• MDR Report Key: 666270
• Date Received: 2005-01-12
• Date of Report: 2005-01-12
• Date of Event: 2003-02-27
• Date Added to Maude: 2006-01-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: CORNEAL TISSUE
• Product Code: LMO
• Date Received: 2005-01-12
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 655645
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2005-01-12