MAUDE Adverse Event Report: UNKNOWN CLITORAL AROUSAL SERUM; LUBRICANT, PERSONAL

Patient Problem Insufficient Information (4580)

Event Date 02/24/2024

Event Type  Other  

Event Description

On february 24th, i made a purchase on lelo.Com including two topical products called nipple play gel and clitoral arousal serum.The outer boxes being damaged, i checked for a consumer safety seal on the inside packaging.The products came in unsealed containers, with no protective tamper-proof barrier or seal to indicate that they were new, unused, and safe for me to use on my body.I requested that the company's customer service confirm that these products were unsealed, and received confirmation by email that they are not sealed by the manufacturer, "bijoux indiscrets are not lelo products, they are packed differently without hygienic seals." i requested that they refund the products, because i did not feel safe using them.Instead, lelo offered me replacement unsealed products (the same items, shipped again, in unsealed containers), and i declined.I sent them the fda link to guidance on packaging, to which they responded that fda rules do not apply to these products.Are these topical products covered by the fda's packaging regulations? please see the products listed on their website here: https://www.Lelo.Com/sensual-accessories.Lelo x bijoux indiscrets.Reference report mw5152905.

• Brand Name: CLITORAL AROUSAL SERUM
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18920709
• MDR Text Key: 337999289
• Report Number: MW5152906
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female