FDA Adverse Event
Injury
Summary report: N
PHOENIX
MDR report key: 24371655
·
Received February 17, 2026
Report
- Report Number
- 3031944951-2026-00001
- Event Type
- Injury
- Date Received
- February 17, 2026
- Date of Event
- January 8, 2026
- Report Date
- February 17, 2026
- Manufacturer
- ROHRER AESTHETICS, INC.
- Product Code
- GEX
- UDI-DI
- 00860564000324
- PMA / PMN Number
- K110434
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IN QUESTION WAS TESTED AT THE USER FACILITY AND FOUND TO BE WITHIN SPECIFICATION. ROHRER'S CLINICAL TEAM REVIEWED BEST TREATMENT PRACTICES FOR THE DEVICE AND PATIENT WITH THE USER FACILITY. WOUND HEALED WITHOUT FURTHER CONCERN.
Description of Event or Problem · 0
3 DAYS POST TREATMENT OF SKIN RESURFACING THE PATIENT REPORTED INFLAMMATION, ERYTHEMA, TISSUE EROSION, AND CRUSTING. PROVIDER INSTRUCTED PATIENT TO KEEP CLOTHING OFF SKIN, USE GENTLY CLEANSER, BYACYN SPRAY AND OCCLUSIVE. PATIENT REFERRED TO URGENT CARE BY PROVIDER FOR ASSESSMENT. PATIENT WAS PRESCRIBED BACITRACIN, KEFLEX AND BACTRIM. PATIENT WAS GIVEN WOUND CARE INSTRUCTIONS BY URGENT CARE PROVIDER. PROVIDER REPORTED A MARKED IMPROVEMENT NOTED WITHIN 48 HOURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 554496 | PHOENIX | POWERED LASER SURGICAL INSTRUMENT | GEX | ROHRER AESTHETICS, INC. | PHOENIX | 00860564000324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |