MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ 1.0 ML

Model Number 40082

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

Patient Problems Fever (1858); Pain (1994); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 04/16/2021

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 follow is a medical opinion based on the information provided in the complaint documented below: it is important to note that the history provided by the injector is lacking the following useful information.Pictures of the patients swollen lips in (b)(6), patients medication history ("daily meds"), topical products applied to lips prior to and after injection, history of previous allergies ( medications and environmental) and the ha type, dose and specific location of filler deposition in the patients lips ( the after photo suggests the filler was primarily injected into the vermillion border).The history provided suggests that the patient is the mother of the injector.Her lips were injected on (b)(6) 2021.The patient then received a covid vaccine (b)(6) 2021.Within 14 days of this event she developed intermittent swollen lips (no photos provided) and dry cracked lips.These symptoms clinical suggest a reaction to topical products, such as a contact dermatitis.Reactions and rashes are well documented with all covid vaccines, with (b)(6) possibly having the most skin reactions.The history does not suggest an allergic reaction to ha filler as the symptoms were delayed (4 months) and intermittent.A reaction to ha product should persist until the product is gone or removed.My clinical opinion is that this case does not represent an adverse event to ha filler.It could represent a localized adverse reaction to the covid vaccine.I trust this medical opinion is of value to all parties involved.".

Event Description

Based on the information provided from injector, patient - female, (b)(6), caucasian.Not first-time lip filler treatment.Patient had various lip fillers over the course of five years.On (b)(6) 2020 first lip treatment.No problems.Lips were perfect.On (b)(6) 2021 lip treatment.No problems.Lips looked and felt perfect.On (b)(6) 2021 woke up and lips were extremely swollen and hurt, felt like a fever.On (b)(6) 2021 top lip swelling lessened but bottom lip still swollen and less painful.On (b)(6) 2021 lips less swollen and not painful but slight burning like chapped lips continued to swell slightly off and on and extremely dry but not as bad until.About (b)(6).Woke up that morning and were extremely swollen and stayed that way for several days.During the night, they were hurting a little.They have just finally returned to fairly normal but still feel like they are burning.Pictures sent to nurse sine they were uncomfortable.Swelling on and off, however, did not go down completely but just less swollen some days.Patient's lips ached all the time.Patient reported that she was given cold compress, benadryl (first two nights) and prednisone (20 milligrams for about three days with no difference) to help lip swelling but nothing has worked except for ice packs.Patient has been diagnosed with covid-19 on (b)(6) 2020 with no symptoms except for psoriasis-like symptoms on her arms.Patient received moderna covid-19 vaccine (b)(6) 2021, after treatment dates.Patient did not take any medications after or before treatment except for her daily medications.State of the patient as of (b)(6) 2021, patient still had some slight swelling but not as severe or the burning.

• Brand Name: REVANESSE VERSA+ 1.0 ML
• Type of Device: REVANESSE VERSA+
• Manufacturer (Section D): 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, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 12071680
• MDR Text Key: 271699009
• Report Number: 3004423487-2021-00013
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10669808001014
• UDI-Public: 10669808001014
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2021
• Device Model Number: 40082
• Device Lot Number: 20B035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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: 71 YR