MAUDE Adverse Event Report: LYNKS ANAL PLEASURE; LUBRICANT, PERSONAL

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 05/07/2021

Event Type  Injury  

Event Description

So there's this line product i've been using for a while and i noticed that there's an ingredient called diazolidinyl urea and realized it's a formaldehyde releaser.Should i be concerned about cancer if i used this casually (like in total i've used 4 bottles of this stuff)? also i i've tried contacting the company and they won't respond to me nor is their website working.Also they've recently changed the ingredient to their product although i have evidence of the products past ingredients.Lynkspleasure products.

• Brand Name: LYNKS ANAL PLEASURE
• Type of Device: LUBRICANT, PERSONAL
• MDR Report Key: 12239565
• MDR Text Key: 264136132
• Report Number: MW5102820
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 72