MAUDE Adverse Event Report: MAX RELAX 2 OZ FORT TROFF; LUBRICANT, PERSONAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Skin Inflammation/ Irritation (4545)

Event Date 04/10/2023

Event Type  Other  

Event Description

Used a product presently sold at this website (https://www.Forttroff.Com/store/product/max-relax -2-oz/) and had horrific bleeding and irritation.

• Brand Name: MAX RELAX 2 OZ FORT TROFF
• Type of Device: LUBRICANT, PERSONAL
• MDR Report Key: 16743717
• MDR Text Key: 313413008
• Report Number: MW5116640
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/10/2023
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: DESCOVY; MAGNESIUM THREONATE; SELEGILINE TRANSDERMAL PATCH; SEROQUEL 100MG
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White, American Indian Or Alaskan Native