MAUDE Adverse Event Report: APYX MEDICAL CORPORATION J-PLASMA

Model Number	GS-018C
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Skin Discoloration (2074); Injury (2348); Patient Problem/Medical Problem (2688)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is considered off label use of the device and not included in the intended uses of these devices.Notice was sent to the physician that this device is not indicated for dermal resurfacing.
Event or Problem Description
Patient reported pain and redness on her face after a dermal resurfacing procedure.Dermal resurfacing is an off-label use of the device.
Additional Manufacturer Narrative
This event is considered off label use of the device and not included in the intended uses of these devices.
Event or Problem Description
Patient reported redness in her face with prolonged recovery time following a dermal resurfacing procedure to treat acne scars.Dermal resurfacing is an off label use of the device.

• Brand Name: J-PLASMA
• Common Device Name: J-PLASMA
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater, fl
• MDR Report Key: 9995171
• Report Number: 3007593903-2020-00018
• Device Sequence Number: 14573546
• Product Code: GEI
• UDI-Device Identifier: 00607151007812
• UDI-Public: 00607151007812
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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 Expiration Date: 08/01/2021
• Device Model Number: GS-018C
• Device Catalogue Number: GS-018C
• Device Lot Number: 0817B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 54