MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Numbness (2415)

Event Date 10/13/2021

Event Type  Injury  

Event Description

Had liposuction and vaser was used.Felt odd pain in my stomach and butt but brushed it off; 9 months post op and i currently can not sit on my butt for too long and stomach pain when i touch my stomach.Also numbness in my lower stomach.Fda safety report id# (b)(4).

• Brand Name: RENUVION
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 14855676
• MDR Text Key: 295109679
• Report Number: MW5110594
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American