MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON REVANESSE VERSA+

Device Problem No Apparent Adverse Event (3189)

Patient Problem Erythema (1840)

Event Type  Injury  

Event Description

Sales person initial report: the injections were done to multiple areas about 1 year ago.Patient/staff member and injector (b)(6) were curious, not that concerned.The red area is where versa was placed but also was placed on other areas that don't turn red.No pain or inflammation.Clinic's report: a staff member patient showed (b)(6) her lower face area after going to the beach/pool and getting sun.The chin area turns red, no inflammation or discomfort.She wears cover up make up when she notices this and goes away in a few days.No other areas she had injected have this reaction.This has been happening every time she gets sun for hours.

• Brand Name: REVANESSE VERSA+
• Type of Device: REVANESSE VERSA+
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON; 138 industrial parkway n; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n,; aurora, ontario L4G 4-C3, ; CA L4G 4C3,
• MDR Report Key: 17231905
• MDR Text Key: 318147376
• Report Number: 3004423487-2023-00024
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic