COPPER C E 52D16 135

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-10 for COPPER C E 52D16 135 manufactured by .

Event Text Entries

[4578506] Not sure but i purchased a new pair of eyeglasses from (b)(6). Name on inside says "copper c e" so evidently has some element of copper in the plastic. My ears have broken out with a bad itchy, scaly rash that hurts. I have an allergy to some metals and evidently the copper they use in the plastic around the ears is one of these metals. Should there be some type of warning with this type of eyewear that alerts a consumer that this may cause a reaction in people with an allergic reaction to metals? I am trying to contact (b)(6) to see if i can get a replacement or some remedy because i paid over (b)(6) and now cannot wear them. Wasn't sure how to report this problem or to whom. I sent email to (b)(6) and tried to find manufacturer site of the eyeglasses but could not find an actual site for copper c e. Thank you. Facility: (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5037260
• MDR Report Key: 3934695
• Date Received: 2014-07-10
• Date of Report: 2014-07-09
• Date of Event: 2014-07-09
• Date Added to Maude: 2014-07-16
• 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: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COPPER C E
• Generic Name: NONE
• Product Code: HQZ
• Date Received: 2014-07-10
• Model Number: 52D16 135
• ID Number: C E
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-07-10