MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML

Model Number	PN40082
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinical complaint was adequately investigated.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 analyzed and it has been determined that product is within required specifications and manufactured according to the appropriate procedures.
Event or Problem Description
The patient initially reported the compliant to the manufacturer.The manufacture has reached out to the nurse injector, who reported that the patient was injected with revanesse versa+ with 3-4ml midface, cheeks, tear troughs, lips.The nurse reports the use of a topical anaesthetic 23/7 lt prior to injection.The nurse and patient has detailed the following adverse events occurring in (b)(6) 2020 product sliding in the "cheek and mid-face".Intermittent and non uniform swelling of specific areas of the lips primarily upon waking.Case was reviewed by the medical director who stats that the migration of the product is due to injection into a suboptimal location or significant pressure applied to the area thru rubbing and massaging.Lip swelling is multifactorial and can be caused by foods, drugs, topicals and excess water or salt intake, especially if there is additional ha in the lip.The medical director has expressed that having reviewed the images provided he cannot see signs of nodules, inflammatory reactions, vascular events, product migration or allergic reactions.Therefore see no clinical or photographic evidence of a product adverse event.

• Brand Name: REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML
• Common Device Name: REVANESSE VERSA+
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC; 138 industrila parkway north; aurora, on ; CA
• MDR Report Key: 11570103
• Report Number: 3004423487-2021-00004
• Device Sequence Number: 19900062
• Product Code: LMH
• UDI-Device Identifier: 10669808001014
• UDI-Public: 10669808001014
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160042/S003
• 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: Nurse Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 01/07/2021
• Device Model Number: PN40082
• Device Catalogue Number: PN40082
• Device Lot Number: 20B037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1