MAUDE Adverse Event Report: VENUS CONCEPT INC. VENUS VIVA RF MICRONEEDLING; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Swelling/ Edema (4577)

Event Date 07/20/2022

Event Type  Injury  

Event Description

Venus viva rf microneedling procedure administered in my dermatologist office on (b)(6) 2022.On (b)(6) 2022 severe swelling, rash, and extreme pruritus.On (b)(6) 2022 symptoms increase and medications called in by the dermatologist involved help very little.The tissue around my eyes is swollen so much that it interferes with my vision.Fda safety report id# (b)(4).

• Brand Name: VENUS VIVA RF MICRONEEDLING
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): VENUS CONCEPT INC.
• MDR Report Key: 15113219
• MDR Text Key: 296784605
• Report Number: MW5111135
• 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: 07/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID 30 MG; CULTURELLE; ROSUVASTATIN 10 MG; SPIRONOLACTONE 25 MG; THERACRAN
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White