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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML

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PROLLENIUM MEDICAL TECHNOLOGIES INC REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML Back to Search Results
Model Number PN40082
Device Problems Device Slipped (1584); Migration (4003)
Patient Problem Swelling/ Edema (4577)
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 patient initially reported the compliant to the manufacturer. The manufacture has reached out to the nurse injector, who reported that the patient was injected with revanesse versa+ with 3-4ml midface, cheeks, tear troughs, lips. The nurse reports the use of a topical anaesthetic 23/7 lt prior to injection. The nurse and patient has detailed the following adverse events occurring in (b)(6) 2020 product sliding in the "cheek and mid-face". Intermittent and non uniform swelling of specific areas of the lips primarily upon waking. Case was reviewed by the medical director who stats that the migration of the product is due to injection into a suboptimal location or significant pressure applied to the area thru rubbing and massaging. Lip swelling is multifactorial and can be caused by foods, drugs, topicals and excess water or salt intake, especially if there is additional ha in the lip. The medical director has expressed that having reviewed the images provided he cannot see signs of nodules, inflammatory reactions, vascular events, product migration or allergic reactions. Therefore see no clinical or photographic evidence of a product adverse event.
 
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Brand NameREVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML
Type of DeviceREVANESSE VERSA+
Manufacturer (Section D)
PROLLENIUM MEDICAL TECHNOLOGIES INC
138 industrila parkway north
aurora, on
CA
Manufacturer (Section G)
PROLLENIUM MEDICAL TECHNOLOGIES INC.
138 industrial parkway north
aurora, on
CA
Manufacturer Contact
ario khoshbin
138 industrial parkway north
aurora, on 
CA  
MDR Report Key11570103
MDR Text Key258411934
Report Number3004423487-2021-00004
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 03/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/07/2021
Device Model NumberPN40082
Device Catalogue NumberPN40082
Device Lot Number20B037
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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