OCU-GUARD UNK

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 2000-01-24 for OCU-GUARD UNK manufactured by Bio-vascular.

Event Text Entries

[177910] Pt rec'd an ocu-guard implant during an unspecified surgical procedure in 1999. Wound dehiscence was noted on 01/2000. Wound was re-sutured but reopened one week later.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2183620-2000-00003
• MDR Report Key: 259874
• Report Source: 05
• Date Received: 2000-01-24
• Date of Report: 2000-01-24
• Date of Event: 2000-01-01
• Date Mfgr Received: 2000-01-14
• Date Added to Maude: 2000-01-28
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: MARY SOBCINSKI
• Manufacturer Street: 2575 UNIVERSITY AVE
• Manufacturer City: ST PAUL MN 55114
• Manufacturer Country: US
• Manufacturer Postal: 55114
• Manufacturer Phone: 6516033703
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• 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: 2000-01-24
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 251674
• Manufacturer: BIO-VASCULAR
• Manufacturer Address: 2575 UNIVERSITY AVE. ST. PAUL MN 55114 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2000-01-24