OCU-GUARD UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2003-11-14 for OCU-GUARD UNK * manufactured by Synovis Surgical Innovations.

Event Text Entries

[295932] Pt underwent enucleation procedure (date unk) followed by implantation of hydroxyapatite orbital prosthesis implant along with ocu-guard orbital implant wrap. At approximately 8 months post-implant, pt presented with exposure, requiring multiple repairs.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2183620-2003-00045
• MDR Report Key: 495769
• Report Source: 03,05
• Date Received: 2003-11-14
• Date of Report: 2003-10-15
• Date Mfgr Received: 2003-10-15
• Date Added to Maude: 2003-11-19
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: PAUL HARTZELL
• Manufacturer Street: 2575 UNIVERSITY AVE W
• Manufacturer City: ST. PAUL MN 551141024
• Manufacturer Country: US
• Manufacturer Postal: 551141024
• Manufacturer Phone: 6516033732
• Manufacturer G1: SYNOVIS SURGICAL INNOVATIONS
• Manufacturer Street: 2575 UNIVERSITY AVE W
• Manufacturer City: ST. PAUL MN 55114102
• Manufacturer Country: US
• Manufacturer Postal Code: 55114 1024
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OCU-GUARD
• Generic Name: ORBITAL IMPLANT WRAP
• Product Code: MTZ
• Date Received: 2003-11-14
• Model Number: UNK
• Catalog Number: *
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 484500
• Manufacturer: SYNOVIS SURGICAL INNOVATIONS
• Manufacturer Address: 2575 UNIVERSITY AVE. W ST. PAUL MN 551141024 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2003-11-14