MAUDE Adverse Event Report: ALMA LASERS, LTD. HARMONY XL; POWERED LASER

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Partial thickness (Second Degree) Burn (2694); Skin Inflammation/ Irritation (4545)

Event Date 03/03/2022

Event Type  Injury  

Event Description

It was reported that a patient experienced small red blisters that became purple and scarred following an acne scars treatment using opus.

Event Description

It was reported that a patient experienced small red blisters that became purple and scarred following an acne scars treatment using opus.

Event Description

Redness and blisters on the chest and neck areas.

• Brand Name: HARMONY XL
• Type of Device: POWERED LASER
• Manufacturer (Section D): ALMA LASERS, LTD.; 18 haharash street; north industrial park; caesarea ha zafon, israel 30798 95; IS 3079895
• MDR Report Key: 13386567
• MDR Text Key: 285950258
• Report Number: 3004450661-2022-00011
• Device Sequence Number: 1
• Product Code: GEX
• 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,Followup
• Report Date: 05/04/2022,05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/03/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/04/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White