FDA.reportPublic FDA data

MAUDE MDR 8497226

MDR report key
8497226
Report number
MW5085706
Event key
0
Event type
3
Date of event
2019-02-01
Date received
2019-04-08
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
1CALVIN KLEIN BLACK LADIES' SUNGLASSESSUNGLASSESUNKNOWNHQYR696S 001 58 16140 #3I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-080

Event Narratives#

D

Patient 1

SUNGLASSES NOTED TO EMIT A VERY STRONG CHEMICAL SMELL AFTER PURCHASE. THE SMELL IS SO POWERFUL THAT I AM UNABLE TO WEAR THEM. THIS IS THE SECOND PAIR OF SUNGLASSES THAT I HAVE PURCHASED THAT HAS THIS PUNGENT CHEMICAL SMELL. THE CHEMICALS USED ARE IRRITATING WHEN BREATHED IN. ESTIMATE DATE OF PURCHASE (B)(6) 2018. (B)(4).