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

Model Number	SPECTRUM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer of rohrer aesthetics, tt aesthetics, reported that a male had 3 tattoo removal treatments for gang related tattoo's, ((b)(6) 2024, (b)(6) 2025, using the spectrum q-switch device.He was scheduled to come in for a 4th treatment on (b)(6) 2025.It was at this time he cancelled his appointment because healing has been slower and he wasn't ready for the next treatment.He then notified them that he went to the emergency room for treatment and was diagnosed with 3rd degree burns.
Additional Manufacturer Narrative
The device is used several times a week on patients and there was no malfunction of the device.We will continue to monitor the health of the patient.
Additional Manufacturer Narrative
The health of the patient has improved on last contact.Device has been in use continually with no other adverse events.User facility and rohrer aesthetics have agreed that this case can be closed.
Event or Problem Description
Follow up and close original report 3031944951-2025-00003.

• 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 ; 9255503094
• MDR Report Key: 22036786
• Report Number: 3031944951-2025-00003
• Device Sequence Number: 15576518
• Product Code: GEX
• UDI-Device Identifier: 00860564000317
• UDI-Public: 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2018
• 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: Male