MAUDE Adverse Event Report: UNKNOWN KAY UNGER EYEGLASSES; EYEGLASSES; EYEWEAR; FRAMES

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2019

Event Type  No Answer Provided  

Event Description

The submitter noticed the proposition 65 warning and believes the product is unsafe.She was upset a product that has a warning about causing reproduction harm and birth defects i being sold.She was also upset that the warning on the product is extremely small which presents consumers from being aware of the potential harm.She does not plan to contact the firm.Retailer:(b)(6).Purchase date: (b)(6) 2019.

• Brand Name: KAY UNGER EYEGLASSES
• Type of Device: EYEGLASSES; EYEWEAR; FRAMES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8760738
• MDR Text Key: 150527829
• Report Number: MW5087883
• Device Sequence Number: 1
• Product Code: HQZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1