MAUDE Adverse Event Report: INTERACTIVE LIFE FORMS, LLC FLESHLUBE PERSONAL LUBRICANT; LUBRICANT, PERSONAL

Model Number FLESHLUBE WATER BY FLESHLIGHT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Local Reaction (2035); Swelling (2091); Urinary Tract Infection (2120)

Event Date 05/27/2020

Event Type  Injury  

Event Description

When switching from one lubricant product to another, the product caused a uti for a male.The product in question is fleshlube - water by fleshlight, a personal lubricant manufactured for sexual health with or without sexual health devices.It is a water based product with other additives that caused an allergic reaction and swelling as well as a uti from trapped bacteria due to swelling from the product outside and inside the male urethra and urinary tract.Occurs when using the product on own or with partners alike.Product was used on its own without an accompanying fleshlight toy sold alongside or separate from fleshlube.Product is made to not degrade specific materials in their items so has additives etc, which may be altering ph or becoming unstable after product has been opened and as it sits compared to when it is first opened.No shelf life is printed on bottles.Item does discolor to a slightly yellowish color and thickens after the main seal is removed within a few days to weeks and after a few uses despite closed cap.Again no expiration date or guidance as to when product should be discarded exists on the packaging of the bottle, no warning statements other than if it causes irritation to seek medical opinion of a physician.I was diagnosed with and am being treated for a male urinary tract infection following use of the product.We were unsure if it was just a fluke, but this is now the third time from the same product.When used with sexual health devices, or on its own during solo or self sexual activity ie masturbation, the product can become lodged and almost trapped in the urinary tract of men where it can cause internal trauma due to thickness and consistency of the product, ph level variances depending on the bottle and the removal of the safety seal for use, can become contaminated via air, etc.And current cap does not sufficiently keep the product air tight.According to multiple urologists this particular product is known to them because of these issues being common among patients in relation to this specific product, brand, and formulation.Many varying patients have reported similar experiences with this particular product in a variety of locations, regardless of retailer, time from initial use of product and forward.Product may also present challenges during washing and removal and may inadvertently also contribute to skin bridging and penile adhesion in circumcised and uncircumcised males regardless of time between use and washing.Skin remains slick even after soap and water washing sometimes for multiple days according to multiple doctors and patients.Temperature associated with classic uti symptomatology in male.Fda safety report id# (b)(4).

• Brand Name: FLESHLUBE PERSONAL LUBRICANT
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): INTERACTIVE LIFE FORMS, LLC; 7000c burleson rd; austin TX 78744
• MDR Report Key: 10114305
• MDR Text Key: 194039752
• Report Number: MW5094806
• 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: 05/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FLESHLUBE WATER BY FLESHLIGHT
• Device Catalogue Number: 810476016036
• Device Lot Number: 5227H4
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 27 YR
• Patient Weight: 86