PLASTIC READING GLASSES FROM THE DOLLAR TREE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-13 for PLASTIC READING GLASSES FROM THE DOLLAR TREE manufactured by Greenbrier International.

Event Text Entries

[114153437] For the past two years, i have been purchasing reading glasses from the (b)(6) here in (b)(6). The glasses are all plastic and are a 2. 00 strength. (i had noticed that coating on these glasses tended to flake off. ) over the next several months, i noticed more and more irritation over my eyelids, temples and behind my ears. I had absolutely no idea what was causing the irritation and thought that i was allergic to something in the environment. So, i went to an allergist who tested me against pollen and other allergies. This test only revealed slight or moderate reaction to these substances. The condition worsened until i went to see a dermatologist who prescribed eurcisa. He wasn't sure if it was plaque psoriasis or contact dermatitis. The ointment seemed to control the irritation but it never went away. So i went to an eye dr who said that i had a lot of skin up on my eyelids and that warm environment might be why i have irritation there. She recommended blepharoplasty to reduce the flesh around the eye. I consented to have the surgery on (b)(6), but was concerned that the condition might spread if the area was aggravated by a surgery. So, on (b)(6) 2018, i went back to my dermatologist with my concern. He said it would not spread and definitively stated that i had was contact dermatitis. He was at a loss as to why it would affect the eyelids, etc. , and then it occurred to me that it was the glasses, "contact dermatitis" dx made sense since the affected areas match exactly how i wear my reading glasses. Plastic reading glasses made in (b)(6). Purchased from: (b)(6). Purchased date: (b)(6) 2017, this date is an estimate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5078392
MDR Report Key7689308
Date Received2018-07-13
Date of Report2018-07-13
Date of Event2017-05-09
Date Added to Maude2018-07-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePLASTIC READING GLASSES FROM THE DOLLAR TREE
Generic NamePLASTIC READING GLASSES FROM THE DOLLAR TREE
Product CodeHOI
Date Received2018-07-13
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerGREENBRIER INTERNATIONAL
Manufacturer Address500 VOLVO PKWY CHESAPEAKE VA 23320 US 23320


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-13

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