MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA 1.0 ML

Model Number 40082

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Discomfort (2330); Injection Site Reaction (4562); Swelling/ Edema (4577)

Event Date 02/28/2021

Event Type  Injury  

Manufacturer Narrative

Prollenium medical technologies' medical director's response to this adverse event was provided to the clinic.The response from medical director is as follows: "the following is a medical opinion based on the information provided in the ae report presented below; the case presented below has three confounding variables which could impact an accurate clinical diagnosis.The versa ifu states as a contraindication not to use versa with or in the same area as another dermal filler such as radiesse.Using two dermal fillers in the mallar region would be considered off label and may contribute to infraorbital edema as seen in this patient, however it has not been studied.The patient received a mrna vaccine which are new in human use and were approved in an expedited manor.The post market surveillance has clearly shown episodes of allergic reactions including periorbital angioedema.Swelling or edema at prior filler sites has also been described due to the pronounced inflammatory response mrna vaccines can excite within the body.Filler site swelling from this cause has been self-limited.The sub orbital swelling seen in the photos provided is exactly along the orbicularis retaining ligament.This is the area patients develop age related "festooning" and therefore it is contraindicated to inject dermal fillers into this area.I therefore assume that the versa was injected into the malar area lateral to the swollen orbicularis retaining ligament.The history mentions that versa was injected into the patients tear troughs however it is interesting to note that the patient has no swelling in this area.This fact makes it less likely that this is inflammatory filler edema caused by the moderna mrna vaccine.My clinical opinion is that this is either periorbital edema from the moderna mrna vaccine or inadvertent injection of ha into the orbicularis retaining ligament.If it is the former it will resolve spontaneously assisted by the use of antihistamines.If the latter is the cause then hyaluronidase should be considered if the swelling does not resolve spontaneously.I do not see evidence of a versa adverse event.I trust this opinion will be of value to all parties involved." prollenium medical technologies inc.Will follow up with the clinic to review the patient status.

Event Description

Based on the information provided, on (b)(6) 2021, patient visited for unanticipated follow-up after reporting adverse event/side effects of fillers under eyes and medial cheeks where ha filler (revanesse versa lot#20f046) was injected by crnp with a canula on (b)(6) 2021.Patient has inquired if swelling could be due to her having received her first moderna covid-19 vaccine (lot#010a21a (b)(6) 2021), expires 8/14/21) on friday (b)(6) 2021.Response of crnp indicated "yes", this is a likelihood.Patient was treated accordingly immediately after electronic message exchange on (b)(6) 2021.On (b)(6) 2021, patient was treated by crnp with a total of 1 ml of revanesse versa (0.5 cc per side) to tear troughs and medial cheeks with cannula.On same day, patient was injected to cheeks with 1.5 cc of radiesse with a needle.Patient described satisfaction with these results and fillers worked "perfect until[?]".Patient received her first moderna covid-19 vaccine (lot#010a21a (b)(6) 2021), expires 8/14/2021) on friday (b)(6) 2021.On (b)(6) 2021, patient awoke that am with "swelling and tightness" under both eyes, and described "felt like a sinus infection".Patient tried cold compresses, which did not help.On (b)(6) 2021, eyes were still swollen, left worse than right, felt tight and uncomfortable.Patient tried tylenol, but it did not help.On (b)(6) 2021, above symptoms persisted.On (b)(6) 2021, patient indicated that under eyes were "more swollen and tight" and "felt hot but not tender", just uncomfortable and she went on to work where co-worker jokingly asked if she has been hit in the eyes.Patient contacted crnp via electronic message at 12:16 pm informing of these issues and onset <48 hours post moderna covid-19 vaccine (lot#010a21a (b)(6) 2021), expires 8/14/2021).Patient denies at anytime experienced any fever, visual changes lip/lower facial swelling, or other signs of systemic illness post-vaccine.Cnrp called in medrol dosepak to (b)(6) just around 12:30pm (b)(6) 2021 and asked patient to start taking it asap, and take otc benadryl by label dosing, if she doesn't have to be alert and driving or working machinery.Patient was to call or text crnp if any problems.Patient was to come to crnp office the next day ((b)(6) 2021) for re-check and documentation of adverse event.On (b)(6) 2021, patient showed up for 10am appointment reporting that she "took all 6 pills" of first dose of medrol dosepack +25 mg of benadryl during her lunch hour the day before.By afternoon of the day before, the swelling has started to decrease.It was better that morning and seems to be subsiding.Patient indicated that she is a little flushed in cheeks since starting the dosepack.Photos taken, in assessment of crnp, the periorbital swelling was in the exact distribution of the ha versa injections.Patient also had radiesse to cheeks that same day (lot 100132569 exp 9/9/2022).The swelling did not appear to be in the distribution of the ha/radiesse injections.Crpn is reporting apparent ae to prollenium medical technologies inc.And merz north america and is planning to report to mederna and fda.At the moment, patient stays the course with dosepack and is to be monitored daily for complete resolution.

• Brand Name: REVANESSE VERSA 1.0 ML
• Type of Device: REVANESSE VERSA
• Manufacturer (Section D): 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: 11634958
• MDR Text Key: 260697367
• Report Number: 3004423487-2021-00006
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P160042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 04/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2021
• Device Model Number: 40082
• Device Lot Number: 20F046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR