MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML

Model Number PN40083

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

Patient Problems Swelling (2091); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The clinical complaint was adequately investigated.It has been confirmed that no previous clinical complaints have been found for the particular lot number in question.The batch record, qc test reports, and training of staff were analyzed and it has been determined that product is within required specifications and manufactured according to the appropriate procedures.

Event Description

The nurse injector reports that the patient female, was injected with revanesse versa+(with lidocaine) 1.2ml in the lips on (b)(6) 2020.No pain or nodularity is experienced.The clinic plans to dissolve the filler in the follow- up visit with the patient.The clinic used a 4% lidocaine topical anesthetic prior to injection.Medical history reported and the patient is not on any medications.She has received ha fillers for the past 3 years (juvederm).The review of a medical doctor was sought by prollenium regarding this case.He believes that recurrent swelling of the lips which resolves with or without treatment suggest an allergic reaction such as angioedema.The most common reasons for this type of reaction is an allergy to foods ( nuts, fruit, shellfish, eggs or dairy) or medications ( antibiotics, aspirin, nsais, ace inhibitors).Allergenic substances applied directly to the lips can also cause these reactions ( lanolin, essential oils, cinnamon or niacin derivatives to name a few).Hyaluronic acid fillers are sugar molecules which are less likely to be antigenic ( allergy inducing ).Reactions to ha fillers would also typically occur closer to the day of injection.That being said if the injecting rn and clinic medical director feel that the ha is an offending agent it should be dissolved with hyaluronidase.This may take 3-4 sessions to completely remove the ha filler.A history of potential offending foods or medications should be taken, as well as consideration to referral for allergy testing.A food diary for days reactions occurred may also offer clues.The manufacturer has requested the clinic to inform of any followup activities.

• Brand Name: REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML
• Type of Device: REVANESSE VERSA+
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway north; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway north; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway north; aurora, L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 11262573
• MDR Text Key: 229821415
• Report Number: 3004423487-2021-00001
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (y/n): N
• PMA/PMN Number: P160042/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PN40083
• Device Catalogue Number: PN40083
• Device Lot Number: 20J080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1