MAUDE Adverse Event Report: WICKED SENSUAL CARE, INC. WICKED SENSUAL CARE AQUA JELLE; LUBRICANT, PERSONAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Caustic/Chemical Burns (2549)

Event Date 05/10/2022

Event Type  Injury  

Event Description

This product burned my vagina.It took over a week for the pain to subside.It's called wicked sensual care aqua jelle lubricant.I looked on the fda site for the product under medical devices after the store manager, i purchased it from directed me to site but i did not find it.The store manager then told me it was clearly an illegal label claim that it was a lubricant if i didn't find it on the site.They said they were going to remove all the wicked sensual care products from the store as none of their products they advertised at lubricants came up on the fda site.There were a lot of them.I tried to call the company directly and they told me basically too bad, they wouldn't even refund my money, and they don't have to clear their lubricant products with the fda.I read all about it online and told them that was a lie that they didn't have to clear these with the fda and i was going to report them to the fda.They said they didn't care, if i caused problems they'd sue me, and then hung of the phone on me! i prefer to stay anonymous in fear of retaliation.These people are crazy.Please do something.Fda safety report id# (b)(4).

• Brand Name: WICKED SENSUAL CARE AQUA JELLE
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): WICKED SENSUAL CARE, INC.; 9030 eton ave.; canoga park CA 91304
• MDR Report Key: 14547446
• MDR Text Key: 293146849
• Report Number: MW5109972
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Hispanic