YSL (SAINT LAURENT) - COUNTERFEIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for YSL (SAINT LAURENT) - COUNTERFEIT manufactured by Kering Eye Wear Spa.

Event Text Entries

[61024727] I ordered a pair of sunglasses from the (b)(6) site which resales clothing and accessory items. The site promises to protect the consumer from counterfeits by accepting returns. The sunglasses that arrived are clearly counterfeit in materials and branding, and (b)(6) will not accept the return. I believe it is dangerous to sell sunglasses that claim to be authentic, but are not. I have no idea what level of eye protection the glasses offer or what materials they are made of. This could be very dangerous to someone expecting eye protection from the glasses. Incident location: home/apartment/condominium - (b)(6), united states. Retailer: (b)(6). Retailer state: (b)(6). Purchase date: (b)(6) 2016. May we include your report, including any documents or photographs that you have attached to your report, but without your name and contact information, in (b)(6) public database: no, do not include my report on (b)(6). I certify that i have reviewed the report and that the information provided in this report is true and accurate to the best of my knowledge, information, and belief: yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5066312
• MDR Report Key: 6127395
• Date Received: 2016-11-23
• Date of Report: 2016-11-14
• Date of Event: 2016-11-14
• Date Added to Maude: 2016-11-25
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: YSL (SAINT LAURENT) - COUNTERFEIT
• Generic Name: SUNGLASSES - BLACK PLASTIC WITH BLACK PLASTIC LENS
• Product Code: HQY
• Date Received: 2016-11-23
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KERING EYE WEAR SPA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-11-23