MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Airway Obstruction (1699)

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient underwent fat liposuction with microaire and submental coagulation.Subsequently, post procedure, the patient experienced hypopharynx edema and hematoma with airway compression.The patient required emergency intubation.The patient was hospitalized for 10 days and is recovering without major sequelae.The surgeon is not sure if renuvion device provoked this deep hematoma/edema leading to airway compromise.However, there was no allegation of device malfunction.

• Brand Name: RENUVION
• Type of Device: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33706-4004 ; 7273842323
• MDR Report Key: 12698913
• MDR Text Key: 278402293
• Report Number: 3007593903-2021-00021
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• 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 Received: 10/08/2021
• 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 Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 53 YR