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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EL.EN. ELECTRONIC ENGINEERING SPA MONA LISA TOUCH; POWERED LASER SURGICAL INSTRUMENT
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EL.EN. ELECTRONIC ENGINEERING SPA MONA LISA TOUCH; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Neuralgia (4413); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/16/2019
Event Type  Injury  
Event Description
I was treated by a mona lisa laser touch device for vaginal rejuvenation and i sustained permanent disabling injury from the device.I began a 3 course treatment.The first two were done by dr.(b)(6) in (b)(6) 2019.I did not have any pain at that time.I then changed doctors and went to dr.(b)(6) for the final treatment on (b)(6) 2019.I then immediately began having severe pain, burning, and nerve pain.I was diagnosed by dr.(b)(6) with padenal neuralgia and vulvodynia.I am currently in pain management and have gotten no relief from my injury.I am unable to some normal day to day activities as a result of my permanent injury and ongoing pain.Fda safety report id # (b)(4).
 
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Brand Name
MONA LISA TOUCH
Type of Device
POWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
EL.EN. ELECTRONIC ENGINEERING SPA
MDR Report Key11613055
MDR Text Key244006590
Report NumberMW5100533
Device Sequence Number1
Product Code GEX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/02/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age52 YR
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