MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES 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	Angioedema (4536)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had immediate swelling that progressively got worse within hours to the point of vascular compression.No pain per patient.Patient directed to the emergency room for im or iv steroid injection.Medrol dose pack, benadryl and zyrtec prescribed by aprn.
Event or Problem Description
On (b)(6) 2023 a patient received 0.6 cc total of revanesse versa+ into her upper and lower lips.The lips were disinfected with 70% isopropyl alcohol immediately prior to the procedure.The patient hadprevious juvederm products injected into their lips.Within 50 mins ( based on photos provided) the patient developed swelling in her lips.The swelling was primarily in her upper lip.Before photo showed an upper andlower lip filled beyond their anatomic borders, implying presence of prior filler.The photo taken 2 hours post injection shows a dermographic rash on a very swollen upper lip with minimal swelling of the lower lip.Thepatient was given a scripts for antihistamines and medrol dose pack and then sent to the emergency department for " im or iv steroids".There was no history of anaphylaxis.Hyluronidase was not used and the filler wasnot dissolved.This reaction represents a case of angioedema.Angioedema can be precipitated by food or drugs or in the case of hereditary angioedema it can be precipitated by stress, alcohol or trauma, such as dental procedures orlip injections.The other possible causes are the use of isopropyl alcohol on mucous membranes or a reaction to ha filler.Isopropyl alcohol is highly toxic to humans as it is rapidly metabolized to acetone in the humanbody.This occurs within 30 minutes.For this reason it cannot be inhaled, ingested or left on the skin.Although the injected ha is in the differential, the fact that the reaction resolved despite the ha not being dissolvedand that the swelling was primarily in the upper lip despite having a small amount of filler in both lips, makes it unlikely to be the cause in this case.The dermographic rash on the upper lip, seen in the photo provided,implies the reaction is more likely to be related to a topically applied substance.The white areas on the lips, which the injector felt were vascular compromise, are more likely caused by the acetone metabolite.My clinical opinion is that this case represents angioedema precipitated by a reaction to isopropyl alcohol applied to the thin epithelium and mucous of the lips.I trust this opinion will be of value to all parties concerned.Internal report 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; 138 industrial parkway n; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n; aurora,, on L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 17967045
• Report Number: 3004423487-2023-00038
• Device Sequence Number: 7965422
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): Y
• PMA/510(K) Number: P160042 S004
• 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
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023
• 2 Devices were Involved in the Event: 1 2

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: 02/07/2025
• Device Model Number: PN40083
• Device Lot Number: 23B063
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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: 33 YR
• Patient Sex: Female
• Patient Race: White