• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PROLLENIUM MEDICAL TECHNOLOGIES REVANESSE VERSA+ (WITH LIDOCAINE) 1.0ML Back to Search Results
Model Number PN40082
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Reaction (2414)
Event Date 08/25/2020
Event Type  Injury  
Manufacturer Narrative
The nurse injector was injected 1. 0 ml of revanesse versa+ with lidocaine into lips (0. 5 ml) and nasolabial folds (0. 5 ml) on (b)(6) 2020. There was no adverse reaction at the time of injection. Patient reported to the nurse injector that she felt reaction next day. Patient states, "since the injections there is whitish rubbery substance that accumulates right between my cheeks and lower gums". Patient has no pain no fever or redness or nothing that could be seen from the outside. There were no signs of any allergic or unintended reaction the day of the procedure. Patient's concern is she will loose the fullness. The batch record and test report for the lot 20g049 were checked and verified. The certificate of analysis, manufacturing batch record checklist, quality control test report and packaging documents were checked and did not find any irregularities in the records. All the records were in compliance with the standards specifications and product has passed. There is no deviation or ncr was associated with this lot.
 
Event Description
Patient was injected 1. 0ml of revanesse versa + with lidocaine into lips (0. 5 ml) and nasolabial folds (0. 5 ml) on (b)(6) 2020. There was no adverse reaction at the time of injection. Patient reported to the nurse injector that she felt reaction next day. Patient states, "since the injections there is whitish rubbery substance that accumulates right between my cheeks and lower gums". Patient has no pain no fever or redness or nothing that could be seen from the outside. There were no signs of any allergic or unintended reaction the day of the procedure. Patient's concern is she will loose the fullness.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREVANESSE VERSA+ (WITH LIDOCAINE) 1.0ML
Type of DeviceREVANESSE VERSA+
Manufacturer (Section D)
PROLLENIUM MEDICAL TECHNOLOGIES
138 industrial parkway north
aurora, ontario L4G 4 C3
CA L4G 4C3
Manufacturer (Section G)
PROLLENIUM MEDICAL TECHNOLOGIES
138 industrial parkway north
aurora, L4G 4 C3
CA L4G 4C3
Manufacturer Contact
ario khoshbin
138 industrial parkway north
aurora, ontario L4G 4-C3
CA   L4G 4C3
MDR Report Key10597050
MDR Text Key208989984
Report Number3004423487-2020-00009
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160042/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse Practitioner
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/13/2022
Device Model NumberPN40082
Device Catalogue NumberPN40082
Device Lot Number20G094
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/28/2020 Patient Sequence Number: 1
-
-