MAUDE Adverse Event Report: ALMA LASERS LTD OPUS WITH COLIBRI TIP

Catalog Number	AASP12091701BA0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperpigmentation (4837)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported about identations following the opus colibri treatment.
Additional Manufacturer Narrative
Indentation and hyperpigmentation in upper cheek following the opus colibri treatment.The lesions have resolved after intervention with other energy based devices treatment.
Additional Manufacturer Narrative
Indentation and hyperpigmentation in upper cheek following the opus colibri treatment.The lesions have resolved after intervention with other energy based devices treatment.Udi related data quality updates: this supplemental report represents a correction to a previously submitted mdr.
Event or Problem Description
It was reported about identations following the opus colibri treatment.

• Brand Name: OPUS WITH COLIBRI TIP
• Common Device Name: 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: 19591680
• Report Number: 3004167969-2024-00017
• Device Sequence Number: 12594262
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: (01)17290110121782(11)221228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/23/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female