MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC., REVANESSE VERSA; NOT CONFIRMED

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Deposits (1809); Nodule (4551)

Event Type  Injury  

Manufacturer Narrative

The manufacturer is attempting to get in touch with the clinic to obtain more information regarding treatment for a medical expert review.

Event Description

The nurse injector reported that the patient was injected with revanesse versa into the marionette lines.Patient has hard rock like accumulations that started 2 months after treatment.Patient was previously injected in the same area with juvederm vollure in june.The manufacturer is attempting to obtain preliminary treatment information form the patient for an expert medical review.The importer facility person of contact has provided the clinic's np with information on treatment on treating delayed onset nodules.

Manufacturer Narrative

(b)(6) 2022, qa has forwarded a notification letter to the clinic to convey the necessity of providing adequate information to enable adequate investigations.No information was provided.A medical assessment could not be made with the limited information provided.Manufacturer has decided to close the case.

Event Description

Based on the information provided by the nurse injector, the patient was injected with revanesse versa in the marionette lines.Patient has hard rock like accumulations that started 2 months after treatment.Patient was previously injected in the same area with juvederm vollure in june.The manufacturer is attempting to obtain preliminary treatment information form the patient for an expert medical review.The manufacturer could not obtain further information from the clinic despite repeated attempts.(b)(6) 2022, qa has forwarded a notification letter to the clinic to convey the necessity of providing adequate information to enable adequate investigations.No information was provided.A medical assessment could not be made with the limited information provided.Manufacturer has decided to close the case.

• Brand Name: REVANESSE VERSA; NOT CONFIRMED
• Type of Device: REVANESSE VERSA; NOT CONFIRMED
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.,; 138 industrial parkway n; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.,; 138 industrial parkway north; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khohsbin ; 138 industrial parkway north; aurora, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 11400326
• MDR Text Key: 234331424
• Report Number: 3004423487-2021-00003
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160042/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other