MAUDE Adverse Event Report: ALMA LASERS LTD FEMILIFT / PIXEL CO2 LASER SYSTEM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 04/27/2023

Event Type  Injury  

Event Description

Patient reported pain in the vaginal area post treatment.

• Brand Name: FEMILIFT / PIXEL CO2 LASER SYSTEM
• Type of Device: PIXEL CO2
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• MDR Report Key: 17388156
• MDR Text Key: 319796140
• Report Number: 3004450661-2023-00010
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2023
• Distributor Facility Aware Date: 05/16/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female