MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES REVANESSE VERSA+ (WITH LIDOCAINE) 1.0ML

Model Number PN40082

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

The nurse injector was injected 1. 0 ml of revanesse versa+ with lidocaine into lips (0. 5 ml) and nasolabial folds (0. 5 ml) on (b)(6) 2020. There was no adverse reaction at the time of injection. Patient reported to the nurse injector that she felt reaction next day. Patient states, "since the injections there is whitish rubbery substance that accumulates right between my cheeks and lower gums". Patient has no pain no fever or redness or nothing that could be seen from the outside. There were no signs of any allergic or unintended reaction the day of the procedure. Patient's concern is she will loose the fullness. The batch record and test report for the lot 20g049 were checked and verified. The certificate of analysis, manufacturing batch record checklist, quality control test report and packaging documents were checked and did not find any irregularities in the records. All the records were in compliance with the standards specifications and product has passed. There is no deviation or ncr was associated with this lot.

Event Description

Patient was injected 1. 0ml of revanesse versa + with lidocaine into lips (0. 5 ml) and nasolabial folds (0. 5 ml) on (b)(6) 2020. There was no adverse reaction at the time of injection. Patient reported to the nurse injector that she felt reaction next day. Patient states, "since the injections there is whitish rubbery substance that accumulates right between my cheeks and lower gums". Patient has no pain no fever or redness or nothing that could be seen from the outside. There were no signs of any allergic or unintended reaction the day of the procedure. Patient's concern is she will loose the fullness.

• Brand Name: REVANESSE VERSA+ (WITH LIDOCAINE) 1.0ML
• Type of Device: REVANESSE VERSA+
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES; 138 industrial parkway north; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES; 138 industrial parkway north; aurora, L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway north; aurora, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 10597050
• MDR Text Key: 208989984
• Report Number: 3004423487-2020-00009
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160042/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/13/2022
• Device Model Number: PN40082
• Device Catalogue Number: PN40082
• Device Lot Number: 20G094
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/28/2020 Patient Sequence Number: 1