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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APYX MEDICAL CORPORATION J-PLASMA
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APYX MEDICAL CORPORATION J-PLASMA Back to Search Results
Model Number APYX-27-TP
Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Patient Problems Dyspnea (1816); Headache (1880); Pneumothorax (2012); Vertigo (2134)
Event Type  Injury  
Event Description
It was reported that post renuvion treatment, a patient had residual helium resulting in pneumomediastinum, pneumoperitoneum, pneumothorax requiring hospitalization.With total resolution, the patient was discharged from the hospital and continues to do well.The event was not related to the performance of the device nor to a malfunction of the device, the device operated as intended.Rather, the use of the device outside of its guidelines is the cause of this event.
 
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Brand Name
J-PLASMA
Type of Device
J-PLASMA
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 Key11912143
MDR Text Key253498338
Report Number3007593903-2021-00009
Device Sequence Number1
Product Code GEI
UDI-Device Identifier00607151050160
UDI-Public00607151050160
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberAPYX-27-TP
Device Catalogue NumberAPYX-27-TP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2021
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) Hospitalization; Life Threatening; Required Intervention;
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