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

Model Number	PN40149
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Event: patient was injected by trainee pa, pre-jowl sulcus area, bolus deep injection.About 15 minutes after injection to the area, the area began to become dusky compared to remainder of the area which was bruised.Patient had a moderate amount of tenderness of that area compared to the rest of the chin and contralateral side of pre-jowl sulcus.This area of injection had a sluggish and delayed capillary refill compared to the surrounding area.Hylenex 2 vials were initially injected into the area.A warm compress was applied, and the area was massaged.The patient was given an asa by owner/injector pa-c.The patient applied the warm compress for 15 minutes and the patient's symptoms were improved.The capillary refill improved slightly.The patient's discomfort improved slightly, and the dusky color improved to a pinkish/purple discoloration.Owner/injector was concerned about possible occlusion although appeared to be more of a vasospasm.She administered another round of hylenex.The area was massaged, and warm compress was applied.Patient monitored for another 15 minutes.Capillary refill improved, but (b)(6) was concerned and administered another vial of hylenex.Heat compress and massage applied, and patient monitored for another 20 minutes.Patient's symptoms improved.Patient was provided with owner's contact information.Patient was seen this by provider/owner at the practice and patient's symptoms improved.Owner stated the patient had bruising and is meeting with a provider with ultrasound to see if area is occluded or is vasospasm.Medical assessment by pmt medical director: my clinical opinion is that this was a case of inadvertent intravascular injection and occlusion, supported by the symptoms and surrounding bruising.Internal report number: (b)(4).
Additional Manufacturer Narrative
N/a.
Event or Problem Description
Event: patient was injected by trainee (b)(6) , pre-jowl sulcus area, bolus deep injection.About 15 minutes after injection to the area, the area began to become dusky compared to remainder of the area which was bruised.Patient had a moderate amount of tenderness of that area compared to the rest of the chin and contralateral side of pre-jowl sulcus.This area of injection had a sluggish and delayed capillary refill compared to the surrounding area.Hylenex 2 vials were initially injected into the area.A warm compress was applied, and the area was massaged.The patient was given an asa by owner/injector pa-c.The patient applied the warm compress for 15 minutes and the patient's symptoms were improved.The capillary refill improved slightly.The patient's discomfort improved slightly, and the dusky color improved to a pinkish/purple discoloration.Owner/injector was concerned about possible occlusion although appeared to be more of a vasospasm.She administered another round of hylenex.The area was massaged, and warm compress was applied.Patient monitored for another 15 minutes.Capillary refill improved, but jennie was concerned and administered another vial of hylenex.Heat compress and massage applied, and patient monitored for another 20 minutes.Patients symptoms improved.Patient was provided with owner's contact information.Patient was seen this by provider/owner at the practice and patient's symptoms improved.Owner stated the patient had bruising and is meeting with a provider with ultrasound to see if area is occluded or is vasospasm.Update in follow up report: the occlusion was confirmed on ultrasound and confirmed cleared after another ultrasound follow up.The patient was monitored for several days post v/o.Medical assessment by pmt medical director: my clinical opinion is that this was a case of inadvertent intravascular injection and occlusion, supported by the symptoms and surrounding bruising.Internal report number: (b)(4).

• Brand Name: REVANESSE LIPS+ (WITH LIDOCAINE) 1.2ML
• Common Device Name: REVANESSE LIPS+
• Manufacturer (Section D): 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: 21493099
• Report Number: 3004423487-2025-00005
• Device Sequence Number: 19832344
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• Combination Product (Y/N): Y
• PMA/510(K) Number: P160042 S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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 Expiration Date: 02/08/2025
• Device Model Number: PN40149
• Device Catalogue Number: NOT AVAILABLE
• Device Lot Number: 23B084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White