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

Model Number 40083

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Local Reaction (2035); Swelling/ Edema (4577)

Event Date 06/12/2021

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 chin, lips, lower eyelid, tear troughs and medial cheeks are to be avoided as stated in the revanesse¿ versatm+ directions for use (dfu) available at www.Http://revanesseusadfu.Com/.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 medical opinion based on the information provided in the complaint outlined below.On (b)(6) 2021 the patient was injected in "several" regions on the face with a total of 1.2 mls of revanesse versa +.The exact areas were not identified in the history, however the photos provided show needle marks over the nasolabial folds, malar prominence, marionette region and stacked smile lines.There is a history of "vaccination" with no further details such as dates ( timing to ha injections).The type of vaccine was also not provided.Clinically mrna vaccines (specifically moderna) have well documented rash ae's.On (b)(6) 2021 it was reported that the patient had " lumps / pustules" under the jawline on one or possibly two sides ( the history and photos make no reference to sides).A physician felt they were not infectious but no further diagnosis was provided.The rash appears to be a non linear small cluster of erythematous papules.These papules do not correspond to rhytides in the region and are nonlinear and so do not correspond to linear needle depositions.The rash is also under the jawline (between the jaw and neck) which would be an unusual area to inject ha, however the history does not identify the actual areas of injection.There are no rashes in the other areas that the photos suggest were injected.Clinically the rash appears to be a contact dermatitis.It has been very common to see rashes in this area secondary to prolonged mask wearing during covid.If the medical director feels that this could represent deposition of product then it has been injected too superficial and should be dissolved.I do not feel that this case represents an adverse event to ha.I trust the clinical opinion is of value to all parties concerned.".

Event Description

Based on the information provided from the clinic, patient - female, (b)(6) y.O., caucasian.Not first-time filler treatment.On (b)(6) 2021 - date of treatment with full syringe of revanesse versa+ 1.2 ml in the jawline area of the patient.On (b)(6) 2021, reaction appeared - bilateral areas along the jawline that appear as acne pustules.Warm to touch.Physician does not feel it is an infection.Upon palpation areas feel like a cord under the skin.After a "week or so" from injection, lumpiness was noticed (tried not to touch anything early).Progressively more prominent and started feeling like "little piles of worms" by 1 month.Medical director has been informed of adverse event.As reported by injector, patient has received covid-19 vaccine.Patient is healthy with reported only medication - crestor and femring.No allergies reported, including to dermal fillers.Other dermal treatments include radiesse-2 syringes.Topical anaesthetic used: bupivacaine/tetracaine/lidocaine (wiped off).According to injector patient does have high cholesterol, menopause, asplenic (no spleen) as of treatment date.No elevated fitzpatrick scales.Cold compresses given.The status of the patient as of (b)(6) 2021 is reported by injector as "stable for now but not regressing yet" and "fine, just would prefer smother areas".

• Brand Name: REVANESSE VERSA+ 1.2 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: 12166438
• MDR Text Key: 261676024
• Report Number: 3004423487-2021-00015
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2023
• Device Model Number: 40083
• Device Lot Number: 21C052
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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: 57 YR