MEDPOR SPHERE UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2005-01-27 for MEDPOR SPHERE UNK manufactured by Porex Surgical.

Event Text Entries

[19158939] Email from pt who received an artificial eye made of medpor material in 1996. Pt was experiencing uncomfortable feeling with blood in tears. Implant was removed in august 2004. Pt was contacted and had the implant removed and was feeling well, but did not provide other info. Product was not returned.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1057129-2005-00005
• MDR Report Key: 568949
• Report Source: 01
• Date Received: 2005-01-27
• Date of Report: 2004-12-30
• Date of Event: 2004-06-23
• Date Added to Maude: 2005-02-01
• 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 Street: 15 DART ROAD
• Manufacturer City: NEWNAN GA 302651015
• Manufacturer Country: US
• Manufacturer Postal: 302651015
• Manufacturer Phone: 6784791610
• 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: MEDPOR SPHERE
• Generic Name: ARTIFICIAL EYE
• Product Code: HQH
• Date Received: 2005-01-27
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: M
• Device Sequence No: 1
• Device Event Key: 558778
• Manufacturer: POREX SURGICAL
• Manufacturer Address: 15 DART RD. NEWNAN GA 302651017 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2005-01-27