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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 Date 06/18/2018
Event Type  No Answer Provided  
Event Description

On (b)(6) 2018 i had my first of a series of 3 laser vaginal rejuvenation done. Then on (b)(6) 2018 i had the second of 3 done. About 18 days approx after my second treatment, i discovered a vaginal lump. On (b)(6) i am seen by my pcp and the diagnosed me with having a bartholin cyst. I mentioned that i was having laser vaginal rejuvenation and she said that it possibly could produce the cyst. After that incident my 3rd treatment was scheduled for (b)(6) 2018 which i called to reschedule and later i was contacted by (b)(6) that all procedures were cancelled due to a fda warning.

 
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Brand NameMONA LISA TOUCH
Type of DevicePOWERED LASER SURGICAL INSTRUMENT
MDR Report Key7772703
Report NumberMW5079051
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 08/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2018
Is This An Adverse Event Report? No
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: 08/09/2018 Patient Sequence Number: 1
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