MAUDE Adverse Event Report: ALMA LASERS LTD OPUS SYSTEM

Catalog Number AASP12091701BA0001

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

Patient Problems Burn(s) (1757); Scar Tissue (2060)

Event Date 11/14/2023

Event Type  Injury  

Event Description

It was reported about a burn following the opus plasma treatment.

Manufacturer Narrative

Burn after opus plasma treatment.Likely will leave a scar.

• Brand Name: OPUS SYSTEM
• Type of Device: OPUS
• 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: 18390441
• MDR Text Key: 331283747
• Report Number: 3004167969-2023-00016
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Report Date: 12/25/2023

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
• Device Catalogue Number: AASP12091701BA0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2020
• Is the Device Single Use?: No
• 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