MAUDE Adverse Event Report: BONAFIDE / JDS THERAPEUTICS LLC / FARMA-DERMA S.R.L. REVAREE; LUBRICANT, PERSONAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burning Sensation (2146)

Event Date 04/01/2021

Event Type  Injury  

Event Description

I started using revaree by bonafide in (b)(6) 2020.I used the product as directed, every 2-3 days, at bedtime.I used the product for a few months but experienced burning so i discontinued it.

• Brand Name: REVAREE
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): BONAFIDE / JDS THERAPEUTICS LLC / FARMA-DERMA S.R.L.
• MDR Report Key: 11841565
• MDR Text Key: 251361949
• Report Number: MW5101387
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): Y
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 45