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

Model Number	Spectrum
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer sent pictures of a patient that had an erbium yag treatement to the face with well defined areas of demarcation and pronounced erythema.Appearance is consistent with concentrated energy delivery.Rohrer clinical made several attempts to obtain treatment details without success.It was made known by the provider that initial post care treatment included neosporin, but switched to vaseline.Provider acknowledged the request for more information but has failed to provide.Rohrer has arranged for additional hand on education and advised to not use the device until this is completed.
Additional Manufacturer Narrative
Rohrer made 3 attempts to obtain treatment details, the only information obtained was the device used and pictures of patient after treatment.We will update case if more information becomes available.

• Brand Name: Spectrum
• 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: 50011316
• Report Number: 3031944951-2026-00005
• Device Sequence Number: 12853653
• 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: User Facility
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2026
• 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