MAUDE Adverse Event Report: LYNK PLEASURE PRODUCTS ANAL LUBE WATER BASED; LUBRICANT, PERSONAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 06/09/2021

Event Type  Injury  

Event Description

Lynk pleasure products anal lube water based from (b)(6).The product created rash due to the ingredient diazolidinyl urea.I have been using this product for a year and concerned if that product can cause cancer due to the amount of diazolidinyl urea.Lynk pleasure products.

• Brand Name: LYNK PLEASURE PRODUCTS ANAL LUBE WATER BASED
• Type of Device: LUBRICANT, PERSONAL
• MDR Report Key: 12226782
• MDR Text Key: 263877973
• Report Number: MW5102787
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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 Age: 29 YR