FDA Adverse Event
Injury
Summary report: N
HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY)
MDR report key: 24373874
·
Received February 17, 2026
Report
- Report Number
- 3004450661-2026-00003
- Event Type
- Injury
- Date Received
- February 17, 2026
- Date of Event
- December 4, 2025
- Report Date
- February 17, 2026
- Manufacturer
- ALMA LASERS LTD.
- Product Code
- GEX
- UDI-DI
- 17290110120907
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE HARMONY XL PRO SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION AND DETERMINED THAT THE BURN LIKELY OCCURRED DUE TO MULTIPLE STACKS OR MULTIPLE PASSES BEING PERFORMED AT THE TREATMENT SITE AND FOUND IIT WAS LIKELY TO RESULT IN A PERMANENT SCAR. ALMA LASERS INC. HAS MADE DUE TO DILIGENCE EFFORTS TO OBTAIN THE DEVICE FOR FURTHER EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED BY THE USER FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422224 | HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY) | POWERED LASER SURGICAL INSTRUMENT | GEX | ALMA LASERS LTD. | 1 | 17290110120907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Other |