MAUDE Adverse Event Report: WICKED SENSUAL CARE LUBRICANT; LUBRICANT, PERSONAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 06/01/2021

Event Type  Injury  

Event Description

I bought a product that was marketed as sexual lubricant by a company called (b)(6) and i got a really bad vaginal infection.I found out after researching on the fda site that it's not an approved lubricant.(b)(6).Fda safety report id# (b)(4).

• Brand Name: WICKED SENSUAL CARE LUBRICANT
• Type of Device: LUBRICANT, PERSONAL
• MDR Report Key: 11966164
• MDR Text Key: 256322635
• Report Number: MW5101778
• Device Sequence Number: 1
• Product Code: NUC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 43 YR
• Patient Weight: 60