MAUDE Adverse Event Report: ALMA LASERS LTD SOPRANO ICE 810 DIODE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Scar Tissue (2060)

Event Type  Injury  

Event Description

Patient reporting scarring on both legs post laser hair removal treatment.

• Brand Name: SOPRANO ICE 810 DIODE
• Type of Device: SOPRANO ICE
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• MDR Report Key: 18465653
• MDR Text Key: 332324937
• Report Number: 3004450661-2024-00001
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2024
• Distributor Facility Aware Date: 01/05/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female