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U.S. Department of Health and Human Services

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

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PROLLENIUM MEDICAL TECHNOLOGIES INC REVANESSE VERSA+ 1.2 ML Back to Search Results
Model Number 40083
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Discomfort (2330); Swelling/ Edema (4577)
Event Date 04/15/2021
Event Type  Injury  
Manufacturer Narrative
The clinical complaint has been adequately investigated. The lot number has been verified and has been confirmed to be released by the company. 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 analysed and it has been determined that product is within required specifications, and manufactured according to appropriate procedures. This complaint is considered as off label use and the clinic have been informed by prollenium medical technologies that injections into unapproved areas such as the lips, lower eyelid, tear troughs and medial cheeks are to be avoided as stated in the revanesse® versatm+ directions for use (dfu) available at (b)(4). 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 clinical medical opinion based on the information provided by the clinic. A treatment plan, as requested, would be of value in assessing this case. Specifically which regions of the upper lip were injected with the 0. 3mls of product, (vermillion or body, central or lateral). Which topical anesthetic was used and at what percentages. What tissue disinfectant was applied prior to and during injection. The after photos clearly show swelling of the upper lip along with erythema and swelling of both cheeks and the chin. The history received claims product was only placed in the lip. The most likely clinical explanation for the facial erythema and swelling is an allergic reaction to a substance applied to these areas such as disinfectant, topical anesthetic or post procedure topical product. Although a reaction to the injected ha is a rare possibility it would only be expected where the product was injected. I trust this opinion is of value to all parties involved. ".
 
Event Description
Based on the information provided, on 15 april 2021, patient received 0. 3 ccs of revanesse versa+ and lips immediately blew up. Nurse was requesting a follow up call and was instructed to call clinic's medical director immediately. Lips more swollen than usual. Used versa- may have had other product in her lips as well. Patients lip and lower face got swollen to the point of causing discomfort, had to reverse product immediately to ease discomfort. No vaccine, patient tested positive for covid in (b)(6). At the time of the procedure, patient tested negative for covid-19. No history of allergies with patient. Topical anesthetic was used during the procedure. Antihistamine (allegra) and medrol dose pack post treatment. Medical director was informed of this adverse event.
 
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Brand NameREVANESSE VERSA+ 1.2 ML
Type of DeviceREVANESSE VERSA+
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 Key11826158
MDR Text Key250747799
Report Number3004423487-2021-00008
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P160042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 05/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number40083
Device Lot Number20L113
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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