MAUDE Adverse Event Report: HOLOGIC/CYNOSURE/EL.EN. ELECTRONIC ENGINEERING SPA MONALISA TOUCH; POWERED LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2020

Event Type  Injury  

Event Description

Has had a total of four treatments and is still having adverse symptoms since the first treatment." my life is destroyed now." she reports that she has read about other women whom gone through the same adverse events as she and reports that this device should not be used for any type of rejuvenation procedure.

• Brand Name: MONALISA TOUCH
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): HOLOGIC/CYNOSURE/EL.EN. ELECTRONIC ENGINEERING SPA
• MDR Report Key: 11108454
• MDR Text Key: 225172945
• Report Number: MW5098644
• Device Sequence Number: 3
• Product Code: GEX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/31/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other