MAUDE Adverse Event Report: ALMA LASERS, LTD. THE ALMA OPUS SYSTEM; OPUS PLASMA

Model Number AASP12091701BA0001

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Scar Tissue (2060); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 08/08/2022

Event Type  Injury  

Event Description

Burn on upper lip.

Event Description

Burn on upper lip.

• Brand Name: THE ALMA OPUS SYSTEM
• Type of Device: OPUS PLASMA
• Manufacturer (Section D): ALMA LASERS, LTD.; 18 haharash street; north industrial park; caesarea ha zafon, ; IS
• MDR Report Key: 15458758
• MDR Text Key: 300294463
• Report Number: 3004450661-2022-00022
• Device Sequence Number: 1
• Product Code: GEI
• 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
• Type of Report: Initial,Followup
• Report Date: 09/20/2022,09/22/2022

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 Operator: Health Professional
• Device Model Number: AASP12091701BA0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2022
• Distributor Facility Aware Date: 08/22/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female