MEDPOR IMPLANT UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-07-29 for MEDPOR IMPLANT UNK manufactured by Porex Surgical, Inc..

Event Text Entries

[1268574] The doctor reported to a distributor that he had six pts that received medpor mandible implants, and each pt developed an infection. The doctor reported that he removed the implants.
Patient Sequence No: 1, Text Type: D, B5

[8270356] The doctor did not provide item or lot # info. After several attempts the doctor did not provide any additional info concerning the removal.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1057129-2009-00007
• MDR Report Key: 1426027
• Report Source: 08
• Date Received: 2009-07-29
• Date of Report: 2009-07-23
• Date Mfgr Received: 2009-06-15
• Date Added to Maude: 2009-08-05
• 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: 0
• Event Location: 0
• Manufacturer Contact: KENT IVERSEN
• Manufacturer Street: 15 DART RD.
• Manufacturer City: NEWNAN GA 30265
• Manufacturer Country: US
• Manufacturer Postal: 30265
• Manufacturer Phone: 6784791610
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDPOR IMPLANT
• Generic Name: FACIAL RECONSTRUCTION
• Product Code: JAZ
• Date Received: 2009-07-29
• Model Number: NA
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: POREX SURGICAL, INC.
• Manufacturer Address: 15 DART RD. NEWNAN GA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2009-07-29