MAUDE Adverse Event Report: ALMA LASERS LTD OPUS COLIBRI

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Scar Tissue (2060)

Event Date 11/29/2023

Event Type  Injury  

Event Description

Hyperpigmentation and indentation post opus colibri treatment.

• Brand Name: OPUS COLIBRI
• Type of Device: OPUS COLIBRI
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• MDR Report Key: 18595921
• MDR Text Key: 333969260
• Report Number: 3004450661-2024-00003
• 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
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2024
• Distributor Facility Aware Date: 01/10/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/29/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female