MAUDE Adverse Event Report: ALMA LASERS LTD SOPRANO ICE

Catalog Number AASP13021204

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2024 it was reported that the patient was hospitalized due to scarring from burns on both legs following the soprano ice treatment.Patient did not provide additional evidence of clinical intervention or recovery.

Event Description

It was reported about a scarring of legs following laser hair removal treatment.

• Brand Name: SOPRANO ICE
• Type of Device: SOPRANO ICE
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer (Section G): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer Contact: avi hirshnzon ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 18555839
• MDR Text Key: 333398540
• Report Number: 3004167969-2024-00002
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: AASP13021204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female