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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APYX MEDICAL CORPORATION APYX ONE CONSOLE; ELECTROSURGICAL GENERATOR

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APYX MEDICAL CORPORATION APYX ONE CONSOLE; ELECTROSURGICAL GENERATOR Back to Search Results
Model Number APYX-ONE
Device Problem Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 10/17/2023
Event Type  Injury  
Event Description
A female patient experienced a burn to their neck in which renuvion was used as part of the overall surgical procedure.
 
Manufacturer Narrative
The patient received a 2rd degree burn on her neck.Temporary and/or permanent injury as a result of a burn is a known potential complication for this technology and treatment.
 
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Brand Name
APYX ONE CONSOLE
Type of Device
ELECTROSURGICAL GENERATOR
Manufacturer (Section D)
APYX MEDICAL CORPORATION
5115 ulmerton road
clearwater FL 33760
Manufacturer (Section G)
APYX MEDICAL CORPORATION
5115 ulmerton road
clearwater FL 33760
Manufacturer Contact
graham cuthbert
5115 ulmerton road
clearwater, FL 33760
MDR Report Key18260506
MDR Text Key329638564
Report Number3007593903-2023-00011
Device Sequence Number1
Product Code GEI
UDI-Device Identifier00607151050221
UDI-Public00607151050221
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K221830
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberAPYX-ONE
Device Catalogue NumberAPYX-ONE
Device Lot Number37441
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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