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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML

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PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML Back to Search Results
Model Number PN40083
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Swelling (2091); Reaction (2414)
Event Type  Injury  
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 Description
The nurse injector reports that the patient female, was injected with revanesse versa+(with lidocaine) 1. 2ml in the lips on (b)(6) 2020. No pain or nodularity is experienced. The clinic plans to dissolve the filler in the follow- up visit with the patient. The clinic used a 4% lidocaine topical anesthetic prior to injection. Medical history reported and the patient is not on any medications. She has received ha fillers for the past 3 years (juvederm). The review of a medical doctor was sought by prollenium regarding this case. He believes that recurrent swelling of the lips which resolves with or without treatment suggest an allergic reaction such as angioedema. The most common reasons for this type of reaction is an allergy to foods ( nuts, fruit, shellfish, eggs or dairy) or medications ( antibiotics, aspirin, nsais, ace inhibitors). Allergenic substances applied directly to the lips can also cause these reactions ( lanolin, essential oils, cinnamon or niacin derivatives to name a few). Hyaluronic acid fillers are sugar molecules which are less likely to be antigenic ( allergy inducing ). Reactions to ha fillers would also typically occur closer to the day of injection. That being said if the injecting rn and clinic medical director feel that the ha is an offending agent it should be dissolved with hyaluronidase. This may take 3-4 sessions to completely remove the ha filler. A history of potential offending foods or medications should be taken, as well as consideration to referral for allergy testing. A food diary for days reactions occurred may also offer clues. The manufacturer has requested the clinic to inform of any followup activities.
 
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Brand NameREVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML
Type of DeviceREVANESSE VERSA+
Manufacturer (Section D)
PROLLENIUM MEDICAL TECHNOLOGIES INC.
138 industrial parkway north
aurora, on L4G 4 C3
CA L4G 4C3
Manufacturer (Section G)
PROLLENIUM MEDICAL TECHNOLOGIES INC.
138 industrial parkway north
aurora, on L4G 4 C3
CA L4G 4C3
Manufacturer Contact
ario khoshbin
138 industrial parkway north
aurora, L4G 4-C3
CA   L4G 4C3
MDR Report Key11262573
MDR Text Key229821415
Report Number3004423487-2021-00001
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P160042/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPN40083
Device Catalogue NumberPN40083
Device Lot Number20J080
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2020
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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