MAUDE Adverse Event Report: ALMA LASERS LTD PIXEL CO2

Catalog Number	AACO01021203
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to patient's report, scar tissue and pain following first pixel co2 treatment.Despite the lack of the information, this report is submitted in good faith.
Event or Problem Description
The patient submitted a self report (mw5162379) to fda about a scar tissue following the pixel co2 treatment on 2021.

• Brand Name: PIXEL CO2
• Common Device Name: CO2
• 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: 21101000
• Report Number: 3004167969-2025-00001
• Device Sequence Number: 15687100
• Product Code: GEX
• UDI-Device Identifier: 17290110120952
• UDI-Public: (01)17290110120952(11)180904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103501
• 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: 505
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: AACO01021203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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