MAUDE Adverse Event Report: ALMA LASERS LTD SOPRANO TITANIUM

Catalog Number	AASP05091845BSR0001
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Burn with subsequent scar after soprano hair removal.The scar will likely be permanent.
Event or Problem Description
It was reported about a burn on right side of the neck after the soprano titanium hair removal treatment.
Additional Manufacturer Narrative
Burn with subsequent scar after soprano hair removal.The scar will likely be permanent.Udi related data quality updates.This supplemental report represents a correction to a previously submitted mdr.
Event or Problem Description
It was reported about a burn on right side of the neck after the soprano titanium hair removal treatment.

• Brand Name: SOPRANO TITANIUM
• Common Device Name: SOPRANO TITANIUM
• 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: 19516775
• Report Number: 3004167969-2024-00015
• Device Sequence Number: 6171489
• Product Code: GEX
• UDI-Device Identifier: 17290110121829
• UDI-Public: (01)17290110121829(11)20231122
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AASP05091845BSR0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Male