MAUDE Adverse Event Report: BTL INDUSTRIES, LTD. EXILIS INTIMA ; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

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

Patient Problem Urinary Retention (2119)

Event Date 10/20/2016

Event Type  Injury  

Event Description

I had a series of four "vaginal rejuvenation" treatments performed in 2016.The treatment was exilis intima.Approx three to four days after the second treatment, i had difficulty urinating some (not every time).Specifically sitting down on the toilet and it was difficult to physically "start" to urinate.Sometimes, took a few moments.This lasted on and off for approx six to nine months and then mostly subsided.I rarely noticed it now but still wanted to report this info.Fda safety report id# (b)(4).

• Brand Name: EXILIS INTIMA
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BTL INDUSTRIES, LTD.
• MDR Report Key: 9686774
• MDR Text Key: 178584292
• Report Number: MW5092867
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1