MAUDE Adverse Event Report: UNKNOWN ALCHEMY LUBE POLAR CHILL WATER BASED LUXURY LUBRICANT; LUBRICANT, PERSONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Burning Sensation (2146); Discomfort (2330); Skin Tears (2516); Swelling/ Edema (4577)

Event Date 05/24/2023

Event Type  Injury  

Event Description

I used a new lube my husband got and didn't think to check the ingredients.I used the lube and almost immediately started swelling.All my genitals internally and externally were extremely swollen.My skin was tearing from the amount of swelling.I was developing burns and sores internally and externally.It was extremely painful my genitals looked like a tomato.After this incident i investigated the ingredients to discover there was menthol crystals in the vaginal lubricant.I immediately called my gynecologist because i was in extreme pain and discomfort.She informed me i need to ensure there was no product left on the skin to prevent further harm.She then told me to take benadryl and use ice.I am seeing my gynecologist a week from the incident to ensure everything healed.My gynecologist also seemed concerned that there was menthol in a product made to go on mucous membranes because menthol isn't supposed to be on a mucous membrane.

• Brand Name: ALCHEMY LUBE POLAR CHILL WATER BASED LUXURY LUBRICANT
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17040171
• MDR Text Key: 316443893
• Report Number: MW5118039
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White