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U.S. Department of Health and Human Services

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

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HOLOGIC / CYNOSURE MONA LISA TOUCH LASER POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Event Date 03/12/2018
Event Type  Injury  
Event Description

I had 4 treatments of mona lisa touch for vaginal rejuvenation (laser treatment), for painful intercourse and frequent urination. My symptoms got worse and intercourse more painful than before.

 
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Brand NameMONA LISA TOUCH LASER
Type of DevicePOWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
HOLOGIC / CYNOSURE
MDR Report Key7813039
Report NumberMW5079365
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation PATIENT
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
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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