MAUDE Adverse Event Report: PURE ROMANCE; GEL LUBRICANT

Device Problems No Fail-Safe Mechanism (2990); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2016

Event Type  malfunction  

Event Description

Purchased product, when received there was no safety seal of any kind.Well because this is a vaginal lubricant, i called the company, spoke to very rude people who said it was not needed according to the fda.Sent them to the fda website where it clearly states it is required.She told me then the people in the warehouse were nice guys and they didn't have to.This is unbelievable and more unbelievable are the women out there using it and not even giving a second thought.

• Brand Name: PURE ROMANCE
• Type of Device: GEL LUBRICANT
• MDR Report Key: 5832850
• MDR Text Key: 50824822
• Report Number: MW5063734
• Device Sequence Number: 1
• Product Code: NUC
• 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: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 58