MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Model Number	APYX-27-TP
Medical Device Problem Codes	Break (1069); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 20 minutes into a subdermal coagulation procedure following liposuction, the tip of the handpiece broke off inside of the patient's left upper quadrant of the abdomen.The handpiece tip broke in the first 3-4 passes.The surgeon attempted to palpate the tip under the skin but he could not feel it as the patient has a lot of fibrosis.The patient was then sent for an x-ray which did not show a foreign body.Renuvion treatment was completed with another cannula.A notification was sent to the surgeon that the apr device used during the subdermal coagulation procedure is made of ceramic materials.This type of material is not radiopaque and therefore, would not show on a x-ray.However, the surgeon does not believe the retained ceramic tip would pose a health risk to the patient and remains inside of the patient.

• Brand Name: RENUVION
• Common Device Name: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 12497741
• Report Number: 3007593903-2021-00016
• Device Sequence Number: 3788184
• Product Code: GEI
• UDI-Device Identifier: 00607151050160
• UDI-Public: 00607151050160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 006071510501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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: APYX-27-TP
• Device Catalogue Number: APYX-27-TP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/20/2021
• 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: Other