MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES REVANESSE LIPS+ - 1.2 ML

Model Number PN40149

Device Problem No Apparent Adverse Event (3189)

Patient Problems Peeling (1999); Nodule (4551)

Event Date 10/03/2022

Event Type  Injury  

Event Description

Date of treatment: (b)(6) 2022.Date of the adverse event reporting to the company (prollenium): 03-oct-2022 (10 days after the injection).Since the injection, she has experienced little white bumps and peeling all over the lips.The filler formed into lumps on one side.Patient has had lip filler many times before, first time using revanesse.

• Brand Name: REVANESSE LIPS+ - 1.2 ML
• Type of Device: REVANESSE LIPS+
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES; 138 industrial pkwy n; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n,; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 15716279
• MDR Text Key: 302872852
• Report Number: 3004423487-2022-00055
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160042 S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/01/2022

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
• Device Model Number: PN40149
• Device Lot Number: 22F125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 11/02/2022
• Date Device Manufactured: 06/06/2022
• 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: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White