MAUDE Adverse Event Report: ALMA LASERS LTD THE ALMA OPUS SYSTEM

Catalog Number AASP12091701BA0001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Scar Tissue (2060)

Event Date 08/08/2022

Event Type  Injury  

Manufacturer Narrative

Atrophic scars after opus treatment, likely due to inadequate contact with skin.Unlikely to heal completely without further treatment.The report was submitted on 14.10.22 in the test mode, and on 21.7.23 it was resubmitted in the production mode.

Event Description

It was reported about atrophic scars after opus treatment.

• Brand Name: THE ALMA OPUS SYSTEM
• Type of Device: OPUS
• Manufacturer (Section D): ALMA LASERS LTD; haharash 18 street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer (Section G): ALMA LASERS LTD; haharash 18 street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer Contact: avi hirshnzon ; haharash 18 street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 17368587
• MDR Text Key: 319479984
• Report Number: 3004167969-2022-00013
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AASP12091701BA0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2022
• 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: 45 YR
• Patient Sex: Female