MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES REVANESSE LIPS +(WITH LIDOCAINE)

Model Number PN40149

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

The lot number 22d109 was verified that has been released by prollenium medical technologies.The batch record (19-apr-2022) and qc final inspection review checklist (21-apr-2022) were analyzed and it has been determined that the product was released with final specifications.The prollenium's medical director's opinion about the reported ae can be found in section b-5.

Event Description

Based on the information/report provided by the clinic (the injector: registered nurse) a patient, a 19-yo female, was injected with 1.2cc of revanesse lips+ into their upper and lower lips on (b)(6) 2023.Two weeks prior the injector dissolved " juvederm" from the patients lips.Prior to the injection on may 11th compounded topical (lidocaine 23% + tetracaine 7% ) anesthetic was applied to the lips.There were no concerns or adverse events at the time of injection.Some time after the injection the patient " experienced feeling the product in her tissue".This was only in her upper lip.There were no concerns with the bottom lip.There was no discolouration, nodules, erythema, edema, inflammation or signs of adverse events.The retrospective review of the batch file shows that no element could explain these issues.The lot number 22d109 was verified and has been confirmed to be released by the company.The batch record, qc test reports, and training of staff were analysed and it had been determined that product is within required specifications, and manufactured according to the appropriate procedures.The batch records and rest of the reports for this lot had passed all tests and a check of the ncr, deviation and oos logs for this lot number has produced zero results.The certificate of analysis (coa) of this lot shows that all testing performed on the product has passed.As part of the investigations, prollenium's medical technologies inc.Had requested its own medical director's opinion and his review is detailed below: "the following is a clinical opinion based on the information provided in case ccr-c-2331.On (b)(6) 2023 a patient received 1.2cc of revanesse lips+ into their upper and lower lips.Two weeks prior the injector dissolved " juvederm" from the patients lips.The reason for this was not provided.Prior to the injection on may 11th compounded topical (lidocaine 23% + tetracaine 7% ) anesthetic was applied to the lips.The technique of "fencing" or vertical struts was used to deposit the product.There were no concerns or adverse events at the time of injection.Some time after the injection the patient " experienced feeling the product in her tissue".This was only in her upper lip.There were no concerns with the bottom lip.There was no discolouration, nodules, erythema, edema, inflammation or signs of adverse events.The after photos provided show a robustly injected upper lip which causes the proportions of the upper to lower lip to appear unnatural.There are also two areas on the upper lip where the product appears more superficial.I assume that the patient is referring to these two clinical observations.My clinical opinion is that this case represents a patient who is not happy with the final result of her filler.I see no evidence of a product adverse event.The patients concerns can be easily resolved by dissolving the superficial product in the upper lip.I trust this clinical opinion will be of value to all parties concerned." internal report number: (b)(4).

• Brand Name: REVANESSE LIPS +(WITH LIDOCAINE)
• Type of Device: REVANESSE LIPS +(WITH LIDOCAINE)
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES; 138 industrial parkway n.; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n.; auroa, 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: 17259736
• MDR Text Key: 318456086
• Report Number: 3004423487-2023-00025
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160042 S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2024
• Device Model Number: PN40149
• Device Lot Number: 22D109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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 Outcome(s): Other
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Race: White