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

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Urinary Retention (2119); Burning Sensation (2146)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: ELECTROSURGICAL, CUTTING, AND COAGULATION
• Manufacturer (Section D): VIVEVE, INC.
• MDR Report Key: 7769568
• Report Number: MW5079010
• Device Sequence Number: 15232073
• Product Code: GEI
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2018
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 55