*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-21 for * manufactured by *.

Event Text Entries

[342646] Pt had uncomplicated right evisceration with hydroxyapatite implant wrapped in donor sclera. One week p/o developed infection (staph) and extrusion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033284
• MDR Report Key: 556360
• Date Received: 2004-09-21
• Date of Report: 2002-04-23
• Date of Event: 2001-11-30
• Date Added to Maude: 2004-11-26
• 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
• 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 Sequence Number: 1

• Brand Name: *
• Generic Name: HYDROXYAPATITE OCULAR IMPLANT
• Product Code: LQF
• Date Received: 2004-09-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 546029
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: *
• Generic Name: DONOR SCLERA
• Product Code: LMO
• Date Received: 2004-09-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 546031
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-09-21