FDA Adverse Event
Injury
Summary report: N
HARMONY XL PRO SYSTEM
MDR report key: 23853530
·
Received December 19, 2025
Report
- Report Number
- 3004450661-2025-00026
- Event Type
- Injury
- Date Received
- December 19, 2025
- Report Date
- December 19, 2025
- Manufacturer
- ALMA LASERS LTD.
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A USER FACILITY REPORTED THAT THEIR PATIENT EXPERIENCED A BURN DURING TREATMENT WITH THE HARMONY XL PRO SYSTEM THAT HAS RESULTED IN HYPOPIGMENTATION. ALMA LASERS INC. WAS UNABLE TO OBTAIN THE NECESSARY INFORMATION FOR AN INVESTIGATION FROM THE USER FACILITY DESPITE PERFORMING SEVERAL DUE DILIGENCE ATTEMPTS. THEREFORE, WE ARE REPORTING THIS INCIDENT IN GOOD FAITH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251909 | HARMONY XL PRO SYSTEM | POWERED LASER SURGICAL INSTRUMENT | GEX | ALMA LASERS LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |