MAUDE Adverse Event Report: PASSION NATURAL WATER-BASED LUBRICANT, 16 FLUID OUNCE; LUBRICANT, PERSONAL

Model Number PL100-16OZ

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Discomfort (2330)

Event Date 08/08/2018

Event Type  Injury  

Event Description

Using the sexual health product "passion lubes, natural water-based lubricant, 16 fluid ounce." i suffered from significant skin irritation on my penis that caused redness, itching, and discomfort after several mins of contact, and lasting for several mins thereafter.Mid redness and itching continued for the next 24-48 hours.The ingredients listed on the product are "purified water, propanediol, citric-acid, hydroxyethylcellulose, hydroxypropyl methylcellulose.Potassium sorbate, sodium benzoate, xanthan gum." fda safety report id# (b)(4).

• Brand Name: PASSION NATURAL WATER-BASED LUBRICANT, 16 FLUID OUNCE
• Type of Device: LUBRICANT, PERSONAL
• MDR Report Key: 8696694
• MDR Text Key: 148063245
• Report Number: MW5087348
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PL100-16OZ
• Device Catalogue Number: 811847014149 683121990087
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 82