MAUDE Adverse Event Report: Rohrer Aesthetics, Inc. Spectrum IPL; Powered Laser Surgical Instrument

Model Number	Spectrum IPL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026the patient presented to the clinic for a spectrum ipl training model."before" photos were taken prior to the treatment.Numbing cream was applied then removed using gauze and alcohol to prep the skin.Ultrasound gel was used during the treatment.The patient tolerated the treatment well and normal response was noted until the provider treated the left upper cutaneous lip.When this area was treated, the patient immediately said it was very painful and the provider stopped and applied ice/contact cooling.No blistering was noted immediately after treatment, however swelling and redness were noted.Treatment areas were cooled down with ice prior to applying sunscreen before the patient left the office.Patient is a natural fitzpatrick skin type ii, however, she did have a notable tan prior to treatment.On (b)(6) 2026 patient returned to the clinic for a follow-up to assess her face post-treatment after calling the office to inform us that she was dissatisfied with her healing progress.The patient reported pain and swelling and visible blisters were noted on the left cheek as well as the left upper cutaneous lip area.The patient was prescribed topical hydrocortisone ointment and topical clobetasol ointment to help with inflammation/swelling/redness and oral doxycycline to treat infection.The patient was also counseled on strict photoprotection to minimize dyspigmentation.On (b)(6) 2026 patient returned to the clinic for a one month follow-up to assess her healing progress.The patient stated that she has scars where she was treated with the ipl device and that she was unhappy with her results.The patient was diagnosed with post-inflammatory hyperpigmentation and an excoriation was still noted in the left upper cutaneous lip area which was injected with intralesional kenalog.The patient was prescribed 8% hydroquinone cream to use twice daily on areas of pih until her next follow-up appointment in 8-12 weeks.On (b)(6) 2026 customer/provider emailed rohrer to report a potential adverse event with before and after pictures, incident report and explanation of treatment events.

• Brand Name: Spectrum IPL
• 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 ; +1(925)550-3094
• MDR Report Key: 50011320
• Report Number: 3031944951-2026-00006
• Device Sequence Number: 15545282
• Product Code: GEX
• UDI-Device Identifier: 00860564000317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: Spectrum IPL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female