OCU-GUARD OG2020SF *

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 1999-07-16 for OCU-GUARD OG2020SF * manufactured by Bio-vascular, Inc..

Event Text Entries

[21398525] Prior to the event, the surgeon performed an enucleation operation on 3/29/1999 on the pt's left eye because of blind and paintful eye. A 20 mm acrylic ocular implant sphere wrapped in ocu-guard (orbital impant wrap) was implanted following the enucleation. The pt had undergone multiple intraocular procedures prior to this enucleation procedure. Description of the event: 04/12/1999, the pt presented with dehiscence of wound with exposed ocu-guard (orbital implant wrap). On 4/15/1999, the surgeon removed the ocu-guard wrapped implant. The pt is reported to be in excellent condition and did not suffer any harm due to this complication.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2183620-1999-00014
• MDR Report Key: 232274
• Report Source: 05
• Date Received: 1999-07-16
• Date of Report: 1999-07-16
• Date of Event: 1999-04-15
• Date Mfgr Received: 1999-06-17
• Device Manufacturer Date: 1998-09-01
• Date Added to Maude: 1999-07-21
• 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
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OCU-GUARD
• Generic Name: ORBITAL IMPLANT WRAP
• Product Code: MTZ
• Date Received: 1999-07-16
• Model Number: OG2020SF
• Catalog Number: *
• Lot Number: 517937
• ID Number: *
• Device Expiration Date: 2003-09-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 225163
• Manufacturer: BIO-VASCULAR, INC.
• Manufacturer Address: 2575 UNIVERSITY AVE. ST. PAUL MN 551141024 US
• Baseline Brand Name: OCU-GUARD
• Baseline Generic Name: ORBITAL IMPLANT WRAP
• Baseline Model No: OG2020SF
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-07-16