ABTOX *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-08 for ABTOX * manufactured by Abtox, Inc..

Event Text Entries

[18166031] Imflamation of the cornea for one yr after cataract surgery in june, 1997.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1013944
• MDR Report Key: 171803
• Date Received: 1998-06-08
• Date of Report: 1998-06-01
• Date of Event: 1997-06-09
• Date Added to Maude: 1998-06-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ABTOX
• Generic Name: PLAZLYTE STERILIZATION EQUIPMENT
• Product Code: FLF
• Date Received: 1998-06-08
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 167080
• Manufacturer: ABTOX, INC.
• Manufacturer Address: 104 TERRACE DR. MUNDELEIN IL 60060 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-06-08