• 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 INC. REVANESSE VERSA+ 1.2 ML

  • 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 INC. REVANESSE VERSA+ 1.2 ML Back to Search Results
Model Number 40083
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Nodule (4551)
Event Date 10/20/2021
Event Type  Injury  
Event Description
Based on the information provided, patient was treated with revanesse versa+ 1. 2 ml on (b)(6) 2021. Patient is female and was born on (b)(6). On (b)(6) 2021, patient was injected in the lips area with revanesse versa+ 1. 2 ml. Volume injected is 0. 8 ml. As reported by injector, five months post injection patient reached out saying that she felt like her upper lip was pulling funny when she smiled and wanted to get it fixed. When patient sent injector the picture, injector immediately saw migration or nodules, injector couldn't tell. Upon seeing patient, injector felt the pockets of filler and was able to dissolve them. The technique injector used to inject is the julie horne technique. On (b)(6) 2021, quality assurance department has reached out to the clinic that patient was treated at, verifying and requesting more information. On (b)(6) 2021, qa department has reached out to clinic regarding requested information. However, clinic has not provided any response. On (b)(6) 2021, qa department has reached out to clinic again regarding requested information. However, clinic has not provided any response. On (b)(6) 2021, clinic was reached out again regarding requested information. However, clinic has not provided any response. On (b)(6) 2021, qa department has reached out to clinic again regarding requested information. However, clinic has not provided any response. After multiple communications with clinic via email, clinic and injector were not responsive and have not provided any information regarding this adverse event as of (b)(6) 2021. Qa department will continue the investigation.
 
Manufacturer Narrative
After multiple communications with clinic and patient via email/telephone, no information regarding this adverse event has been received as of 29 nov 2021 besides initial notification information. Qa department will continue the investigation. Prollenium medical technologies' medical director's response to this adverse event will be provided to the clinic once requested information will be received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREVANESSE VERSA+ 1.2 ML
Type of DeviceREVANESSE VERSA+
Manufacturer (Section D)
PROLLENIUM MEDICAL TECHNOLOGIES INC.
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 Key12888067
MDR Text Key281523665
Report Number3004423487-2021-00026
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P160042 S015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Patient Monitoring
Type of Report Initial,Followup
Report Date 12/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number40083
Device Lot Number21A094
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-