MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; REVUVION

Model Number BVX-200P

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Myalgia (2238); Ventilator Dependent (2395); Low Oxygen Saturation (2477); Renal Impairment (4499); Unspecified Musculoskeletal problem (4535)

Event Date 07/27/2021

Event Type  Death  

Event Description

It was reported to apyx medical corporation by dr.(b)(6), that on (b)(6) 2021, he performed the following procedures on a patient; microaire liposuction, breast reduction from 590cc to 350cc with inverted t and gluteal implant removal and lipograft in the gluteal area of 400cc each and subdermal coagulation treatment with renuvion to the the upper, middle and lower back, abdomen and inner legs.The total surgical time was 5 hours.Other technologies were possibly involved in this event, however, at this time it is unknown.Post procedure, the patient presented with severe pain in the areas where liposuction was performed.Subsequently, the patient's creatinine level was elevated and a diagnosed of rhabdomyolysis was made.Prior to surgery the patient's creatinine level was within normal limits.The patient complained of pain, however, the amount of pain was unusual to dr.(b)(6).No bruising or notorious ecchymosis was detected.Initially, the patient was treated with paracetamol and ketoprofeno.The following day, the patient became hypotensive, sleepy and the pain continued.Tramadol was administered and the patient was sent to another hospital emergency room.This hospitals assessment noted that when pressure was applied to the areas of pain, the patient's condition improved enough for her to speak.Ct scans were taken to rule out fluids in the intraperitoneal cavity and thromboembolism.Subcutaneous helium emphysema was detected but not found not to be the source of the problem.The patient's creatinine levels increased (2mg /dl).The evaluating nephrologist reported that the patient appeared as if she had extensive burns and recommended dialysis and hydration.The patient's oxygenation levels dropped and she was subsequently intubated.Further tests were performed and an indirect diagnosis of thrombosis was ruled.The patient was then put on dialysis with no improvement as her hemoglobin levels continued to drop.The patient could not be stabilize and unfortunately expired at 11pm on (b)(6) 2021.The patient passed away from what was determined to be acute renal failure.However, no autopsy was performed.Although there was no alleged malfunction of the apyx device, with the available information, a reasonable conclusion could not be made to determine if the apyx medical device caused or contributed to the patient death.

• Brand Name: RENUVION
• Type of Device: REVUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 12379942
• MDR Text Key: 268563847
• Report Number: 3007593903-2021-00013
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10607151011755
• UDI-Public: 10607151011755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BVX-200P
• Device Catalogue Number: BVX-200P
• Device Lot Number: 0421J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening