NONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-18 for NONE manufactured by .

Event Text Entries

[5009011] I am filing a concern, not a complaint. I believe (b)(4) sold the eyeglass frames i purchased from them in good faith and did not know these frames could have a detrimental effect on the wearer. At a recent vision exam, i was told the reason i was having difficulty with power vision was hat the frames i was using had been made in (b)(4) where low grade metals are often used in products. I also became aware that continual use of these frames was resulting in an allergic reaction, causing congestion and pain along the side of my nose and circling up under my eyebrow. Now that i am wearing a hypoallergenic frame, not made in (b)(4), my vision has improved as well as a dramatic improvement in my nasal passages. Loss: not filing for reimbursement. Relief requested: i would appreciate your informing (b)(4) that they are selling eyeglass frames made in (b)(4) that have caused at least one customer to have difficulty with vision as well as an allergic reaction. I do not want to return these frames for a refund but want to send them to some agency which can perform a chemical analysis that can determine what toxins are present and provide documentation, so that these frames cannot be sold in the united states. Please let me know where i can send these frames. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5039198
MDR Report Key4270823
Date Received2014-11-18
Date of Report2014-09-29
Date Added to Maude2014-11-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNONE
Generic NameEYEGLASS FRAME
Product CodeHQZ
Date Received2014-11-18
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2014-11-18

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