MAUDE Adverse Event Report: ALMA LASERS LTD OPUS PLASMA

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

Patient Problem Scar Tissue (2060)

Event Date 11/14/2023

Event Type  Injury  

Event Description

Scarring post opus plasma treatment.

• Brand Name: OPUS PLASMA
• Type of Device: OPUS PLASMA
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• MDR Report Key: 18325112
• MDR Text Key: 330486997
• Report Number: 3004450661-2023-00020
• 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: Other
• Type of Report: Initial
• Report Date: 12/14/2023

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2023
• Distributor Facility Aware Date: 11/16/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female