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

Model Number	PN40083
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	06/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Based on the information/report provided by the injector, [ (b)(6), np] a 61 yo female, was injected with 1.2 ml revanesse versa+ (with lidocaine) in lips on (b)(6) 2022.There were no concerns or adverse events at the time of injection.There was no reported past medical history.In (b)(6) 2023, the patient felt several small lumps (about 10) in her lips with no pain of inflammation.She was seen by her pcp and a dermatologist before she contacted the injector.The patient was put on an "antibiotic" (abx) and reported a noticeable (40%) improvement.The patient declined an offer to dissolve the product.The batch record, qc test reports (29-jun-2022), and qc final inspection review check list (08-jul-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 22f183 was verified and has been confirmed to be released by the company.The information provided by the clinic has been submitted to the prollenium 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 (b)(4).On (b)(6) 2022 a patient received 1.2 cc of revanesse versa +, into her lips.There were no concerns or adverse events at the time of injection.There was no reported past medical history.In (b)(6) 2023, the patient felt they had several small lumps in their lips.She was seen by her pcp and a dermatologist before she contacted the injector.No collateral medical history such as vaccines or infections was provided.The injector felt there was no erythema or inflammation.The patient was put on an "antibiotic" and reported a noticeable improvement.The patient declined an offer to dissolve the product.My clinical opinion is that this may represent a case of delayed nodules secondary to a coexisting infectious condition.These adverse events usually resolve completely with time and treatment." internal prollenium complaint number: (b)(4).
Additional Manufacturer Narrative
He batch record, qc test reports (29-jun-2022), and qc final inspection review check list (08-jul-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 22f183 was verified and has been confirmed to be released by the company.The information provided by the clinic has been submitted to the prollenium 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 (b)(4).On (b)(6) 2022 a patient received 1.2 cc of revanesse versa +, into her lips.There were no concerns or adverse events at the time of injection.There was no reported past medical history.In (b)(6) 2023, the patient felt they had several small lumps in their lips.She was seen by her pcp and a dermatologist before she contacted the injector.No collateral medical history such as vaccines or infections was provided.The injector felt there was no erythema or inflammation.The patient was put on an "antibiotic" and reported a noticeable improvement.The patient declined an offer to dissolve the product.My clinical opinion is that this may represent a case of delayed nodules secondary to a coexisting infectious condition.These adverse events usually resolve completely with time and treatment." internal prollenium complaint number: (b)(4).

• Brand Name: REVANESSE VERSA+(WITH LIDOCAINE) 1.2 ML
• Common Device Name: REVANESSE VERSA+(WITH LIDOCAINE) 1.2 ML
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial pkwy n.,; auora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n; aurora, ontario ; CA
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n.; aurora, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 17559673
• Report Number: 3004423487-2023-00030
• Device Sequence Number: 19732982
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160042 S004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2024
• Device Model Number: PN40083
• Device Lot Number: 22F183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Race: White