ABTOX ABT 1.0 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-16 for ABTOX ABT 1.0 * manufactured by Abtox, Inc..

Event Text Entries

[16278080] Md reports cornea degeneration. Facility used abtox system to sterilize surgical instruments until 4/1/98.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 201945
• MDR Report Key: 201945
• Date Received: 1998-12-16
• Date of Report: 1998-10-02
• Date of Event: 1998-03-31
• Report Date: 1998-10-02
• Date Reported to Mfgr: 1998-10-02
• Date Added to Maude: 1998-12-17
• Event Key: 0
• Report Source Code: User Facility 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: 3
• Report to FDA: 3
• 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 SYSTEM
• Product Code: FLF
• Date Received: 1998-12-16
• Model Number: ABT 1.0
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Age: 6 MO
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 196152
• Manufacturer: ABTOX, INC.
• Manufacturer Address: 104 TERRACE DRIVE MUNDELEIN IL 60060 US
• Baseline Brand Name: PLAZLYTE STERILIZER
• Baseline Generic Name: GAS STERILIZER
• Baseline Model No: ABT 1.0
• Baseline Catalog No: PL006-01-02
• Baseline ID: *
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K905119
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-12-16