MAUDE Adverse Event Report: APYX MEDICAL CORPRATION J-PLASMA

Model Number	BVX-330B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Patient Problem/Medical Problem (2688)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Possible factors that may have contributed to this issue include the amount of energy delivered to the treated area, patient compliance with post-procedure instructions, and physician technique.The ifu states that combined therapies using other technologies may cause unwanted burns, skin contour irregularities, scarring, pigmentation changes and increased healing time.The reported complaint is not attributed to a device malfunction.
Event or Problem Description
A patient had a procedure performed to treat localized adiposity and extreme laxity of the neck and lower face that included vibration assisted liposuction followed by renuvion.There were no complications immediately following the procedure.On a post-operative follow up 4 months later, the patient presented with subdermal bunching in the neck area.

• Brand Name: J-PLASMA
• Common Device Name: J-PLASMA
• Manufacturer (Section D): APYX MEDICAL CORPRATION; 5115 ulmerton road; clearwater, fl
• MDR Report Key: 9949488
• Report Number: 3007593903-2020-00011
• Device Sequence Number: 14270927
• Product Code: GEI
• UDI-Device Identifier: 00607151010157
• UDI-Public: 00607151010157
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2020

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 Model Number: BVX-330B
• Device Catalogue Number: BVX-330B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2020
• Initial Report FDA Received Date: 04/10/2020
• 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: Disability
• Patient Age: 68 YR