MAUDE Adverse Event Report: RA MEDICAL SYSTEMS, INC PHAROS EXCIMER LASER SYSTEM; EXCIMER PHOTOTHERAPY LASER

Model Number	EX=308
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	01/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A service technician inspected the device at the user facility and no device deficiencies were observed.Device was operating within specifications.
Event or Problem Description
It was reported that after treatment for a dermatological condition on the legs and arms, the patient experienced unexpected erythema with blistering and weeping.Healthcare professional reported that the patient is healing well.User facility protocol to treat erythema is to apply a thin layer of hyton with aquaphor twice daily, in addition to decreasing the dose by 100-200 mj/cm2 and not treating effected areas until fully healed.Healthcare professional stated that patient has a history of erythema after treatment.The dose delivered at time of event was 500 mj/cm2.The dose delivered at the previous treatment was 400 mj/cm2.Reportedly, the patient had not applied any topicals or photosensitizing agents prior to treatment.No additional patient or event information is available.

• Brand Name: PHAROS EXCIMER LASER SYSTEM
• Common Device Name: EXCIMER PHOTOTHERAPY LASER
• Manufacturer (Section D): RA MEDICAL SYSTEMS, INC; 2070 las palmas drive; carlsbad, ca CA 92011
• MDR Report Key: 11407680
• Report Number: 2032864-2021-00002
• Device Sequence Number: 14298371
• Product Code: GEX
• UDI-Device Identifier: 00842362100017
• UDI-Public: (01)00842362100017(11)20190829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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: EX=308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention