MAUDE Adverse Event Report: THOR PHOTOMEDICINE LTD THOR PHOTOMEDICINE LTD; 810NM 16W LASER CLUSTER (80X200MW) ISSUE 2, PRODUCT CODE: ILY

Model Number	S2195
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Partial thickness (Second Degree) Burn (2694)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Practitioner used the glc on a patient who has had this same treatment many times.After they got home, they reported what they thought looked like a burn mark on the skin, the patient did not report any discomfort or sensation at the time of treatment.
Additional Manufacturer Narrative
The practitioner reported that the patient had previously attended ten appointments for the same treatment, using the same laser probe, with identical settings, duration, and application to some of the same body areas, without any adverse effects.Since the patient reported this event, the practitioner noted that the patient remained fine and unconcerned.They also noted that the same probe had been used subsequently on several other patients, staff members, and even themselves without any reports of heating, burning, or other adverse effects.Since 2021, over 100 of these probes have been in regular use, typically multiple times per day, resulting in thousands of patient treatments without any reported adverse events.Additionally, experimental use of the probe for up to six minutes on a single anatomical location revealed no significant heating or adverse effects.Investigations are ongoing to determine whether other factors contributed to or caused this incident.The probe has been requested to be returned for testing.

• Brand Name: THOR PHOTOMEDICINE LTD
• Common Device Name: 810NM 16W LASER CLUSTER (80X200MW) ISSUE 2, PRODUCT CODE: ILY
• Manufacturer (Section D): THOR PHOTOMEDICINE LTD; units 1 & 2 anglo office park; white lion road; amersham, buckinghamshire HP7 9 FB; UK HP7 9FB
• Manufacturer (Section G): THOR PHOTOMEDICINE LTD; units 1 & 2 anglo office park; white lion road; amersham, buckinghamshire HP7 9 FB; UK HP7 9FB
• Manufacturer Contact: ian clinch ; units 1 & 2 anglo office park; white lion road; amersham, buckinghamshire HP7 9-FB ; UK HP7 9FB
• MDR Report Key: 20890997
• Report Number: 3003899624-2024-00007
• Device Sequence Number: 7902554
• Product Code: ILY
• UDI-Device Identifier: 05060494130558
• UDI-Public: (01)05060494130558(11)210920
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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: S2195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2021
• 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
• Patient Sex: Female