WALGREENS ONE STEP DISINFECTING SOLUTION *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-08 for WALGREENS ONE STEP DISINFECTING SOLUTION * manufactured by Sauflon Pharmaceuticals, Ltd..

Event Text Entries

[309885] Pt experienced burning in their eyes upon using the solution and required medical attention.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2438562-2004-00010
• MDR Report Key: 521183
• Date Received: 2004-04-08
• Date of Report: 2004-02-04
• Date of Event: 2004-01-07
• Date Facility Aware: 2004-02-04
• Report Date: 2004-02-04
• Date Reported to Mfgr: 2004-02-05
• Date Added to Maude: 2004-04-21
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• 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: WALGREENS ONE STEP DISINFECTING SOLUTION
• Generic Name: HYDROGEN PEROXIDE LENSCARE SYSTEM
• Product Code: MRC
• Date Received: 2004-04-08
• Model Number: *
• Catalog Number: *
• Lot Number: UNK
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 510291
• Manufacturer: SAUFLON PHARMACEUTICALS, LTD.
• Manufacturer Address: * TWICKENHAM, MIDDELSEX UK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-04-08