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Model Number 40083
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Numbness (2415); Paresthesia (4421)
Event Date 05/17/2021
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 www. Http://revanesseusadfu. Com/. Prollenium medical technologies' medical director's response to this adverse event was provided to the clinic. "the following is a medical opinion based on the potential adverse event outlined below; on (b)(6) 2021 the patient received 1. 2 mls of versa ha into their lip. For 20 minutes prior to injection, 23% lidocaine plus 7% tetracaine in plo ( an absorption agent) was applied to the patients lip. The patient received the (b)(6) vaccine sometime prior to this date. There is a history of latex allergy. There was no filler put into the cheeks according to the history and photos provided. Three to four hours after injection the patient described numbness and tingling in both cheeks. There was no swelling, erythema, lumps or symptoms in the lips. The photos provided show no swelling, redness, lumps or reaction in either the lips or cheeks. There was no rash described or seen in the photos. The was no signs or symptoms of allergic reaction or angioedema. There is no evidence in the history or photos provided to indicate a reaction to versa ha. In my medical opinion this is not an adverse event to versa ha. I trust this opinion will be of value to all parties concerned. ".
Event Description
Based on the information provided, on (b)(6) 2021, patient - female, (b)(6) y. O. , (b)(6). Not first-time lip filler treatment. Patient has been injected with 1. 2 ml of revanesse versa+ into lips. On (b)(6) 2021, three hours post procedure, patient reported redness, numbing and tingling sensations to both cheeks. Post treatment plan included dissolving the dermal fillers 2 days post procedure with 150iu hyalundrinase reconstituted with 2 ml bacteriostatic nacl 9%, distributed evenly in the injected areas, per patient request. 4 days later, the patient returned to dissolve more filler she felt was still leftover. The injector administered the same dose and reconstitution of hyalundrinase in the same areas and focusing on the right upper and left lower lip. Patient reported to have had ¿ syringe of juvederm dernal filler to lips more than 6 months ago as of (b)(6) 2021. Patient reported that she was given cold compress and reported prescribed prednisone and antihistamines by pcp. Patient received first shot of covid-19 (b)(6) vaccine prior to initial treatment. Topical anesthetic used: topical lidocaine 23%, tetracaine 7% pro cream applied to lips for 20 minutes prior to injecting. Patient did not have pre-existing risk factors. Patient reported history of allergy to latex gloves, which were not used during the procedure.
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Manufacturer (Section D)
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 Key12020097
MDR Text Key257146672
Report Number3004423487-2021-00012
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
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 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number40083
Device Lot Number21C106
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial