MAUDE Adverse Event Report: VIVEVE, INC. GENEVEVE; ELECTROSURGICAL, CUTTING, AND COAGULATION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Urinary Retention (2119); Burning Sensation (2146)

Event Date 04/24/2018

Event Type  Injury  

Event Description

Radiofrequency "rejuvenation" procedure in dermatology office.No pain or adverse effects until 10-14 days later.Painful upper anterior vagina in area of 2001 bladder surgery, burning with urination, felt like bladder infection starting, and sense of not being able to fully empty my bladder began.This lasted for the next 4-6 weeks and has finally resolved.I took some antibiotics nightly and have been fine, 3 months after the procedure.I experienced no benefit and am concerned that had symptoms not gone away.I would suffer a lot of regret and maybe more uti's.

• Brand Name: GENEVEVE
• Type of Device: ELECTROSURGICAL, CUTTING, AND COAGULATION
• Manufacturer (Section D): VIVEVE, INC.
• MDR Report Key: 7769568
• MDR Text Key: 116930401
• Report Number: MW5079010
• Device Sequence Number: 1
• Product Code: GEI
• 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: 08/03/2018

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 55