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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
Event Type  Injury  
Event Description

Dr. (b)(6) did the mona lisa touch treatment on me. I was just a $ sign to her and i'm suffering ever since. I was given the mona lisa touch treatments by dr (b)(6). I was told that she should have never touch me because my pain was in my urethra not my vagina. I have been in urethra pain ever since she has done these treatments to me. I have seen numerous drs who cannot help me. I am on pain meds and have tried medical marijuana which did not alleviate the pain. I have no quality of life and am suffering. I wish i could not take pain meds but the pain is unbearable. I have been told that i have nerve problem now.

 
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Brand NameMONA LISA TOUCH
Type of DevicePOWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
EL. EN. ELECTRONIC ENGINEERING SPA
MDR Report Key8331562
Report NumberMW5083896
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 02/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2019
Is This An Adverse Event Report? Yes
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: 02/11/2019 Patient Sequence Number: 1
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