MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC REVANESSE VERSA+ 1.2 ML

Model Number 40083

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Discomfort (2330); Swelling/ Edema (4577)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

The clinical complaint has been adequately investigated.The lot number has been verified and has been confirmed to be released by the company.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 analysed and it has been determined that product is within required specifications, and manufactured according to appropriate procedures.This complaint is considered as off label use and the clinic have been informed by prollenium medical technologies that injections into unapproved areas such as the lips, lower eyelid, tear troughs and medial cheeks are to be avoided as stated in the revanesse® versatm+ directions for use (dfu) available at (b)(4).Prollenium medical technologies' medical director's response to this adverse event was provided to the clinic.The response from medical director is as follows: "the following is a clinical medical opinion based on the information provided by the clinic.A treatment plan, as requested, would be of value in assessing this case.Specifically which regions of the upper lip were injected with the 0.3mls of product, (vermillion or body, central or lateral).Which topical anesthetic was used and at what percentages.What tissue disinfectant was applied prior to and during injection.The after photos clearly show swelling of the upper lip along with erythema and swelling of both cheeks and the chin.The history received claims product was only placed in the lip.The most likely clinical explanation for the facial erythema and swelling is an allergic reaction to a substance applied to these areas such as disinfectant, topical anesthetic or post procedure topical product.Although a reaction to the injected ha is a rare possibility it would only be expected where the product was injected.I trust this opinion is of value to all parties involved.".

Event Description

Based on the information provided, on 15 april 2021, patient received 0.3 ccs of revanesse versa+ and lips immediately blew up.Nurse was requesting a follow up call and was instructed to call clinic's medical director immediately.Lips more swollen than usual.Used versa- may have had other product in her lips as well.Patients lip and lower face got swollen to the point of causing discomfort, had to reverse product immediately to ease discomfort.No vaccine, patient tested positive for covid in (b)(6).At the time of the procedure, patient tested negative for covid-19.No history of allergies with patient.Topical anesthetic was used during the procedure.Antihistamine (allegra) and medrol dose pack post treatment.Medical director was informed of this adverse event.

• Brand Name: REVANESSE VERSA+ 1.2 ML
• Type of Device: REVANESSE VERSA+
• Manufacturer (Section D): 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, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 11826158
• MDR Text Key: 250747799
• Report Number: 3004423487-2021-00008
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (y/n): N
• PMA/PMN Number: P160042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 40083
• Device Lot Number: 20L113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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
• Patient Age: 35 YR