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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONA LISA TOUCH TREATMENT POWERED LASER SURGICAL INSTRUMENT

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MONA LISA TOUCH TREATMENT POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Event Date 01/01/2018
Event Type  Injury  
Event Description

Had vaginal rejuvenation with laser from gyn. She did 4 treatments instead of three because it did not seem to work and burned. I believe scarring has occurred because the pain during and now for a week following intercourse is extreme.

 
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Brand NameMONA LISA TOUCH TREATMENT
Type of DevicePOWERED LASER SURGICAL INSTRUMENT
MDR Report Key7769685
Report NumberMW5079018
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 08/04/2018
1 Device Was Involved in the Event
1 Patient Was 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 HEALTH PROFESSIONAL
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

Patient TREATMENT DATA
Date Received: 08/08/2018 Patient Sequence Number: 1
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