MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML

Model Number PN40083

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  Injury  

Event Description

A patient recounted a narrative that the she was injected with revanesse versa.Her account indicated that she was treated in the marionette lines, nasolabial folds and chin and reported scarring.No clinic medical director narrative was provided.No images were provided.No treatment plan, nor medical history was provided.Prollenium has requested supplemental information on four occasions.Prollenium plans to follow up with supplemental requests for the relevant information with which our investigation can proceed.

Manufacturer Narrative

The clinic has not provided us with the requested information.The clinic says they have not written anything down.No information, no treatment, no injection information, etc.Have been recorded by the clinic.The clinic and patient have not provided any images, so far.

Event Description

The clinic has provided images of pre- and post-treatment with further information on their company letterhead on (b)(6) 2024.

Manufacturer Narrative

Some information provided in this follow up-1 report are additional information; some are correction; the corrections are the adverse event problem codes (section h.6), and manufacturer report number.

• Brand Name: REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML
• Type of Device: REVANESSE VERSA+ (WITH LIDOCAINE)
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES, AURORA, ON; 138 industrial parkway n; aurora, on L4G 4 C3,; CA L4G 4C3,
• Manufacturer (Section G): 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 Key: 18766491
• MDR Text Key: 336062392
• Report Number: 3004423487-2024-00002
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PN40083
• Device Lot Number: 23C209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: White