MAUDE Adverse Event Report: ROHRER AESTHETICS, INC. PHOENIX; POWERED LASER SURGICAL INSTRUMENT

Model Number	PHOENIX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Discoloration (2074)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: PHOENIX
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ROHRER AESTHETICS, INC.; 121 citation court; homewood 35209
• Manufacturer (Section G): ROHRER AESTHETICS, INC.; 121 citation court; homewood 35209
• Manufacturer Contact: sandra hansen ; 121 citation court; homewood 35209 ; 9255503094
• MDR Report Key: 24371655
• Report Number: 3031944951-2026-00001
• Device Sequence Number: 4914083
• Product Code: GEX
• UDI-Device Identifier: 00860564000324
• UDI-Public: 00860564000324
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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
• Operator of Device: Health Professional
• Device Model Number: PHOENIX
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female