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U.S. Department of Health and Human Services

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

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VIVEVE, INC. GENEVEVE ELECTROSURGICAL, CUTTING, AND COAGULATION Back to Search Results
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.

 
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Brand NameGENEVEVE
Type of DeviceELECTROSURGICAL, CUTTING, AND COAGULATION
Manufacturer (Section D)
VIVEVE, INC.
MDR Report Key7769568
Report NumberMW5079010
Device Sequence Number1
Product CodeGEI
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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