MAUDE Adverse Event Report: UBERLUBE UBERLUBE; LUBRICANT, PERSONAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)

Event Type  Other  

Event Description

Ineffective and vaginal irritation.(b)(6).Hcp did not consent to follow up.(b)(4).

• Brand Name: UBERLUBE
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): UBERLUBE
• MDR Report Key: 16953460
• MDR Text Key: 315540128
• Report Number: MW5117634
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1