MAUDE Adverse Event Report: JEISYS MEDCAL INC. POTENZA

Catalog Number	105-7043-000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Itching Sensation (1943); Swelling/ Edema (4577)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced swelling and itching on the face following a rf microneedling treatment using potenza.Cynosure's clinical team investigated the event and confirmed user error was involved.Operator performed two passes with s-25 tip followed by another two passes with l-25 tip.Labeling recommends: two passes with either tip, but not both.Patient also had mature skin.Per clinical's assessment: treatment performed was too aggressive on the patient's skin.Based on the labeling materials and risk review, swelling is an expected side effect from such treatments.Patient was given oral prednisone as medical intervention.This is a reportable adverse event due to patient receiving medical intervention.

• Brand Name: POTENZA
• Common Device Name: POTENZA
• Manufacturer (Section D): JEISYS MEDCAL INC.; 307, 96, gamasan-ro; geumcheon-gu, seoul 08501 ; KS 08501
• MDR Report Key: 18985767
• Report Number: 1222993-2024-00014
• Device Sequence Number: 18238108
• Product Code: GEI
• UDI-Device Identifier: 08800020111012
• UDI-Public: (01)08800020111012(11)191228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2024
• Report Date (Section F): 03/27/2024

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 Catalogue Number: 105-7043-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/27/2024