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

Model Number	PN40149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The batch record, qc test reports (24-aug-2022), and qc final inspection review check list (01-sep-2022) were analyzed and it has been determined that the product was released within final release specifications.The retrospective review of the batch file shows that no element could explain these issues.The lot number 22h133 was verified and has been confirmed to be released by the company.
Event or Problem Description
As per the injector (and the clinic medical doctor), np, 0.4 ml, twice, 2 weeks apart of revanesse lips +(with lidocaine) was injected to the lips of a female on 15-nov-2023.No concern or adverse event was reported at the time of injection.Post - injection, the patient stated her lips were quite dry and have stayed that way since her injections in november of 2023.She just informed the injector of this issue on march 28, 2024, so it has been occurring for just over 4 months.Provider would like to know if there is a possible causal relationship between lip injections with revanesse lips and dry, peeling lips.On 09-apr-2024, the injector, in response to the pmt's email (to request further information about ae), said that she was able to see the patient in person and asked more questions.Turns out it was all from dehydration and not the filler as she also started on a weight loss product.Around the same time she had done fillers and has not been drinking enough water.The injector has requested pmt not to further investigate the reported ae.The batch record, qc test reports (24-aug-2022), and qc final inspection review check list (01-sep-2022) were analyzed and it has been determined that the product was released within final release specifications.The retrospective review of the batch file shows that no element could explain these issues.The lot number 22h133 was verified and has been confirmed to be released by the company.The information provided by the clinic has been submitted to the prollenium's medical director for review.The medical director's opinion about the reported ae is as follows: the following is a clinical opinion based on the information provided in case ccr-c-2419.On november 15, 2023 a patient received 0.8 cc of revanesse lips+ into their lips.There were no concerns or adverse events reported.The patient was seen for a touch up 2 weeks later.Once again everything was fine.On march 28, 2024 the patient reported that her lips felt " more dry".No other symptoms were reported.The injector reached out to prollenium to ask if there was any possible relationship with lip filler.When further information and photos were requested the injector responded " thanks you for getting back to me.I was able to assess the patient in person and was able to ask more questions.Turns out the patient started on a weight loss product at the time of the filler and had been drinking less water.Her concerns were not from the filler but rather the weight loss product and inadequate hydration.I don't feel this needs to be investigated, but thank you! " my clinical opinion is that this case does not represent an ha adverse event, which is supported by the opinion of the injector.Internal ae report no: (b)(4).

• Brand Name: REVANESSE LIPS+ (WITH LIDOCAINE), 1.2 ML
• Common Device Name: REVANESSE LIPS+ (WITH LIDOCAINE), 1.2 ML
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): 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: 19231952
• Report Number: 3004423487-2024-00006
• Device Sequence Number: 5665765
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160042 S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2024
• Device Model Number: PN40149
• Device Lot Number: 22H133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female