EYE GLASSES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-25 for EYE GLASSES manufactured by .

Event Text Entries

[1903825] To whom it may concern: hello, my name is (b)(6). I am a prisoner in (b)(6). I have a question for you. I saw on t. V. The toy scare out of (b)(6) a couple of years ago where toys were contaminated with lead. I was wondering if there have been any cases of eye glasses contaminated with lead or anything else? I've got a pair of glasses from (b)(6) where the clear coating on the frames has started to wear off and now it seems like the skin under my eyes on the sides of my nose is extremely dry, sore, fleaky. No matter what i do to try to moisturize it, it just won't heal. All i can think of is, it's my glasses. I've never had this problem with my skin it's always been clear. Would this be a symptom of skin in continuous contact with a contaminant? My glasses are 2 1/2 years old. Thank you for your time. (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5019111
• MDR Report Key: 1971679
• Date Received: 2011-01-25
• Date of Report: 2010-12-23
• Date Added to Maude: 2011-02-01
• 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: 0
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EYE GLASSES
• Generic Name: EYE GLASSES
• Product Code: HQZ
• Date Received: 2011-01-25
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-01-25