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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
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Event Date 10/26/2021
Event Type  Injury  
Event Description
It was reported to apyx medical corporation that while undergoing a subdermal coagulation procedure on the inner thighs, the patient experienced severe hypotension and decreased heart rate.It was noted that this patient did not have enough incision sites for gas egress in effort to make as few incisions as possible for "aesthetic reasons".The gas buildup during the procedure was the cause of the hypotension and decreased heart rate.The probable cause of this adverse event and the use of the equipment is due to lack of proper training and compliance with all the protocols of apyx medical corporation.
 
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Brand Name
RENUVION
Type of Device
RENUVION
Manufacturer (Section D)
APYX MEDICAL CORPORATION
5115 ulmerton road
clearwater FL 33760 4004
Manufacturer (Section G)
APYX MEDICAL CORPORATION
5115 ulmerton road
clearwater FL 33760 4004
Manufacturer Contact
aylin canlar
5115 ulmerton road
clearwater, FL 33760-4004
7273842323
MDR Report Key13009022
MDR Text Key282260300
Report Number3007593903-2021-00032
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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