MEDPOR IMPLANTS 6317

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2005-01-27 for MEDPOR IMPLANTS 6317 manufactured by Porex Surgical.

Event Text Entries

[393298] Porex surgical's distributor representative reported that pts had experienced "bloody, swollen" eyes after implantation of orbital spheres.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1057129-2005-00001
• MDR Report Key: 568863
• Report Source: 01,08
• Date Received: 2005-01-27
• Date of Report: 2005-01-23
• Date of Event: 2004-11-09
• Date Mfgr Received: 2004-11-09
• 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 Contact: KENT IVERSEN
• Manufacturer Street: 15 DART ROAD
• Manufacturer City: NEWNAN GA 30265
• Manufacturer Country: US
• Manufacturer Postal: 30265
• Manufacturer Phone: 6784791610
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDPOR IMPLANTS
• Generic Name: FACIAL AUGMENTATION & RECONSTRUCTION
• Product Code: MBS
• Date Received: 2005-01-27
• Model Number: 6317
• Catalog Number: 6317
• Lot Number: UNK
• ID Number: UNK
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 558692
• Manufacturer: POREX SURGICAL
• Manufacturer Address: 15 DART RD. NEWNAN GA 30265 US
• Baseline Brand Name: MEDPOR IMPLANTS
• Baseline Generic Name: FACIAL AUGMENTATION & RECONSTRUCTION
• Baseline Model No: 6317
• Baseline Catalog No: 6317
• Baseline ID: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-01-27