*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-06 for * manufactured by Midwest Eye Laboratories.

Event Text Entries

[316830] Caller wears protective lens which they describe as a thin shell over an existing eye injury. While waiting in the office to have this lens painted, they started sneezing from strong paint smell. After wearing lens for 2 days, still was sneezing and now coughing, had lower back pain and bloody stools. Went to chiropractor who said their back pain may be due to kidney problems. Caller is currently not using lens to see if symptoms go away.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027733
• MDR Report Key: 446540
• Date Received: 2003-03-06
• Date of Report: 2003-03-06
• Date of Event: 2003-02-20
• Date Added to Maude: 2003-03-10
• 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
• Reporter Occupation: PATIENT
• 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: *
• Generic Name: PROTECTIVE LENS
• Product Code: HQT
• Date Received: 2003-03-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 435510
• Manufacturer: MIDWEST EYE LABORATORIES
• Manufacturer Address: 1101 WEST CLAIREMONT AVE SUITE 1-D EAU CLAIRE WI 54701 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-03-06