MAUDE Adverse Event Report: CHONGQING PENINSULA MEDICAL TECHNOLOGY CO., LTD.; 308nm Excimer System

Model Number	308nm Excimer System
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction

• Common Device Name: 308nm Excimer System
• Manufacturer (Section D): CHONGQING PENINSULA MEDICAL TECHNOLOGY CO., LTD.; c1-8, c2-8, b1-8, building #10; erlang, jiulongpo district; chong qing, 40003 9; CH 400039
• Manufacturer (Section G): CHONGQING PENINSULA MEDICAL TECHNOLOGY CO., LTD.; c1-8, c2-8, b1-8, building #10; erlang, jiulongpo district; chong qing, 40003 9; CH 400039
• Manufacturer Contact: zhang di ; c1-8, c2-8, b1-8, building #10; erlang, jiulongpo district; chong qing, 40003-9 ; CH 400039
• MDR Report Key: 50690816
• Report Number: 3015060197-2026-00000
• Device Sequence Number: 9595193
• Product Code: FTC
• UDI-Device Identifier: 06971777450036
• UDI-Public: 06971777450036
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K172273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 308nm Excimer System
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2023
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 211 LB