MAUDE Adverse Event Report: ROHRER AESTHETICS PHOENIX CO2

Model Number	Phoenix
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A rohrer customer incorrectly treated a patient with a co2 device causing 3rd degree burns to the patient.The customer had not received any training for the device.However, the customer decided to treat a patient without training of the device.The patient was admitted to the burn unit 2 days after the adverse event.Our service engineer inspected the device on (b)(6) 2022 and found the device to be in complete working order.The laser met all calibration and power standards as set by the fda.The customer has not been forthcoming with details of the patient.I was only able to ascertain background and ethnicity from pictures.

• Brand Name: PHOENIX CO2
• Common Device Name: PHOENIX CO2
• Manufacturer (Section D): ROHRER AESTHETICS; 105 citation court; homewood AL 35209
• Manufacturer Contact: mike portera ; 105 citation court; homewood, AL 35209 ; 2059402200
• MDR Report Key: 15180283
• Report Number: 3011593504-2022-00001
• Device Sequence Number: 20327268
• Product Code: GEX
• UDI-Device Identifier: 00860564000324
• UDI-Public: (01)00860564000324(11)220401
• Combination Product (Y/N): N
• PMA/510(K) Number: K110434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2022

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
• Device Model Number: Phoenix
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White