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U.S. Department of Health and Human Services

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

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MONA LISA TOUCH POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Event Type  No Answer Provided  
Event Description

Had 3 monalisa touch treatments and my symptoms have not improved and may be worse. I was treated for vaginal dryness/discomfort and minor incontinence.

 
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Brand NameMONA LISA TOUCH
Type of DevicePOWERED LASER SURGICAL INSTRUMENT
MDR Report Key7746812
Report NumberMW5078854
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 07/31/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/02/2018
Is This An Adverse Event Report? No
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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