MAUDE MDR 7689308

MDR report key
7689308
Report number
MW5078392
Event key
0
Event type
3
Date of event
2017-05-09
Date received
2018-07-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PLASTIC READING GLASSES FROM THE DOLLAR TREEPLASTIC READING GLASSES FROM THE DOLLAR TREEGREENBRIER INTERNATIONALHOII Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-130

Event Narratives#

D

Patient 1

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.