MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ 1.2 ML

Model Number	40083
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's account: "back on (b)(6) ( (b)(6)to be exact) i was a model for the clinic.The next day and that night i had a horrible reaction and i reached out to them later on, i received a phone call from a person in clinic who had me go to a walk-in clinic because they think it was just allergies, which it wasn't).I had to pay for a visit to that clinic, who prescribed me the benadryl and prednisone that didn't really help).After going back and forth, and a review on bbb, the clinic had me reach out to someone that would dissolve the fillers.On the day before i came down with covid-like symptoms so i canceled my appointment, doing the right thing.When i'd attempted to reschedule and said covid, a woman there freaked out.The clinic would not make a new appointment, using the reason for possible covid which was negative.I was told that if i took down my bbb review perhaps she could find another doctor, which she did.However, that doctor is 3 hours away.Last month i saw a doctor, who supposedly dissolved the fillers but it did not work.I've tried reaching out to the clinic but she has not responded.I asked what was used on my face and that's when they told me it was revanesse).This has been a nightmare and i'm hoping you can help me.I look like there are rocks in my face.Again, had i known i never would have agreed.Whatever that "dr" used did not dissolve the fillers.I had no idea they were students for i was told they were medical professionals." clinic's account: "on the evening on (b)(6), patient emailed office to let us know that she was experiencing hard lumps and was running a fever.She had mentioned she was in excruciating pain- inside and out.Office saw the e-mail, and called the patient.Put her in contact with an on-call provider, who suggested she go to urgent care in the event of an allergic reaction.She went and was treated at urgent care facility.A couple of weeks later patient was worried about unevenness.Sent to an md in the area, who saw very minimal lumps.".

• Brand Name: REVANESSE VERSA+ 1.2 ML
• Common Device Name: REVANESSE VERSA+ 1.2 ML
• 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, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 17097294
• Report Number: 3004423487-2023-00020
• Device Sequence Number: 1932020
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2023

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: Other
• Device Expiration Date: 09/05/2024
• Device Model Number: 40083
• Device Lot Number: LOT# 22I061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: White