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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EL. EN. ELECTRONIC ENGINEERING SPA MONA LISA TOUCH LASER, A MINIMALLY INVASIVE LASER TREATMENT POWERED LASER SURGICAL (INSTRUMENT)

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EL. EN. ELECTRONIC ENGINEERING SPA MONA LISA TOUCH LASER, A MINIMALLY INVASIVE LASER TREATMENT POWERED LASER SURGICAL (INSTRUMENT) Back to Search Results
Event Date 02/17/2018
Event Type  Injury  
Event Description

I received the promising mona lisa touch (mlt) procedure inside the vagina, from (b)(6), and began suffering from new and excruciating side effects. I have the following new side effects in the vagina: scar tissue, tearing inflammation, utis, sensitivity and prone to vaginal infections. I am unable to have a sexual relationship with my husband as promised from the nurses at the mlt introduction and this has created a lot of mental stress. Several cultures were done by dr nicole m. Hook to rule out sids and other possible disease, which is irrelevant as i am unable to perform sexually and my husband and i do not have other partners. Did the problem stop after the person reduced the dose or stopped taking or using the product? no. Did the problem return if the person started taking or using the product again? yes. How was it taken or used? vaginal; date the person first started taking or using the product: (b)(6) 2017; date the person stopped taking or using the product: (b)(6) 2018. Reason for use: i was promised quick and painless restored vaginal health.

 
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Brand NameMONA LISA TOUCH LASER, A MINIMALLY INVASIVE LASER TREATMENT
Type of DevicePOWERED LASER SURGICAL (INSTRUMENT)
Manufacturer (Section D)
EL. EN. ELECTRONIC ENGINEERING SPA
MDR Report Key8133536
Report NumberMW5081837
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 12/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/04/2018
Is This An Adverse Event Report? Yes
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

Patient TREATMENT DATA
Date Received: 12/04/2018 Patient Sequence Number: 1
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