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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; PLASMA/RF HANDPIECE
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APYX MEDICAL CORPORATION RENUVION; PLASMA/RF HANDPIECE Back to Search Results
Model Number APYX-15-TP
Medical Device Problem Codes Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event 10/07/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Patient presented one day post-operative with a third degree burn.The investigation concluded that the issue is associated with poor surgical technique and poor patient selection.There is no reported malfunction of the device.
 
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Brand Name
RENUVION
Common Device Name
PLASMA/RF HANDPIECE
Manufacturer (Section D)
APYX MEDICAL CORPORATION
5115 ulmerton road
clearwater FL 33760 4004
MDR Report Key10875134
Report Number3007593903-2020-00026
Device Sequence Number11470264
Product Code GEI
UDI-Device Identifier00607151050153
UDI-Public00607151050153
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K191542
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/20/2020
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 Date05/01/2023
Device Model NumberAPYX-15-TP
Device Catalogue NumberAPYX-15-TP
Device Lot Number0520H
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/21/2020
Initial Report FDA Received Date11/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
LIPOSUCTION
Outcome Attributed to Adverse Event Disability;
Patient Age42 YR
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