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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION
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APYX MEDICAL CORPORATION RENUVION Back to Search Results
Model Number APYX-27-TP
Medical Device Problem Codes Use of Device Problem (1670); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes Burn(s) (1757); Blister (4537)
Date of Event 04/28/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that subdermal use of the device following a liposuction procedure, a patient sustained a burn to the treated area.The patient subsequently developed a blister to the treated area and underwent a skin grafting procedure for treatment.This event represents an over treatment at a pivot point.There was no report of performance issues with the handpiece or delivery generator.
 
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Brand Name
RENUVION
Common Device Name
RENUVION
Manufacturer (Section D)
APYX MEDICAL CORPORATION
5115 ulmerton road
clearwater FL 33760 4004
MDR Report Key11929845
Report Number3007593903-2021-00008
Device Sequence Number4345281
Product Code GEI
UDI-Device Identifier00607151050160
UDI-Public00607151050160
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/01/2021
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 NumberAPYX-27-TP
Device Catalogue NumberAPYX-27-TP
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/09/2021
Initial Report FDA Received Date06/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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