MAUDE Adverse Event Report: ALMA LASERS LTD SOPRANO ICE

Catalog Number	AASP13021204, ICE122002812 HP
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Burn after soprano ice hair removal on chest and neck.Likely will lead to a permanent scar or hyperpigmentation.
Event or Problem Description
It was reported about burns of breasts and neck area.
Event or Problem Description
It was reported about burns of breasts and neck area.
Additional Manufacturer Narrative
Burn after soprano ice hair removal on chest and neck.Likely will lead to a permanent scar or hyperpigmentation.Udi related data quality updates: this supplemental report represents a correction to a previously submitted mdr.

• Brand Name: SOPRANO ICE
• Common Device Name: 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: 18666618
• Report Number: 3004167969-2024-00004
• Device Sequence Number: 7271236
• Product Code: GEX
• UDI-Device Identifier: 17290110121003
• UDI-Public: (01)17290110121003(11)180402
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• 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
• Device Catalogue Number: AASP13021204, ICE122002812 HP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2018
• 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 Sex: Female