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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Cyst(s) (1800)
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 Name
MONA LISA TOUCH
Type of Device
POWERED LASER SURGICAL INSTRUMENT
MDR Report Key7772703
MDR Text Key117000839
Report NumberMW5079051
Device Sequence Number1
Product Code GEX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
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
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age51 YR
Patient Weight78
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