MAUDE Adverse Event Report: EL.EN. ELECTRONIC ENGINEERING SPA MONA LISA TOUCH LASER; POWERED LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Pain (1994); Suicidal Ideation (4429); Drug Resistant Bacterial Infection (4553)

Event Date 07/01/2013

Event Type  Injury  

Event Description

Was informed by my gynecologist that the mona lisa touch would help prevent uti's, and prevent common issues for women my age.After completing this treatment, my bladder pain became so severe that i became suicidal, and now have constant bladder infection, including a resistant bacteria.My pain never goes away now.My urologist performed a custom and there is no lining left in my bladder, just a big red irritated mess.I can no longer have sex.Fda safety report id# (b)(4).

• Brand Name: MONA LISA TOUCH LASER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): EL.EN. ELECTRONIC ENGINEERING SPA
• MDR Report Key: 11301204
• MDR Text Key: 230960047
• Report Number: MW5099296
• Device Sequence Number: 1
• Product Code: GEX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: D MANNOSE
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 86