MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Based on the information provided, the patient got injected with revanesse dermal fillers in the upper left lip area of the patient on an unspecified date.The lot of the product injected was not provided and, therefore, not verified.According to the initial communication, amount of product injected was described as an extremely small amount of the filler into client's upper left vermillion boarder/cupid's bow with adverse issue no issue or reaction".Injector then went on to place filler in a thread like fashion in her left lower lip.After placement of filler in her left lower lip, the injector evaluated the left upper lip and noted an increased amount of swelling.Injector placed an ice pack over the lip with good response/decrease in swelling.Injector went on to complete her right lower lip, lower vermillion boarder, and right upper lip.There was an increase amount of swelling also noticed in the right lower lip.Injector placed ice over the entire lip with a good response and decrease in swelling.Injector then went back to evaluated the left upper lip.There was good capillary refill, pink color, and blood return when the lip was poked with a syringe.The patient had good sensation with minimal discomfort.Injector called local sales manager and was placed in contact with another area representative and informed him of situation.Injector immediately sought assistance from other medical professionals to assist in helping injector care for client and resolve her issue.Date of birth not provided.No information regarding topic anaesthetic has been provided.No information regarding allergies has been provided.No information regarding medical history and presence of risk factors have been provided.After follow up and assessing the patient the following day, the injector determined that patient had a vascular occlusion in the area of injection.Patient was treated with 25 vials of hylenex and now has capillary refill at approx.3 seconds with no reticularis noted and patient appears to be "normal" without tissue necrosis or vesicle formation since the day of notification, the qa department has attempted to contact the injector and clinic again to inquire additional information regarding the event, however no response has been received.As of (b)(6) 2022, no response from the clinic has been received.The qa department at prollenium medical technologies will continue the investigation.

Manufacturer Narrative

The clinical complaint is in the process of investigation.The lot number has not been verified due to the absence of information.It will be confirmed whether any clinical complaints have been found for the particular lot number in question once requested information is provided.The batch record, qc test reports, and training of staff will be analysed and be determined that product is within required specifications, and manufactured according to appropriate procedures once lot is verified.Prollenium medical technologies' medical director's response to this adverse event will be provided to the clinic along with the letter indicating approved areas for injection for revanesse versa+ and revanesse lips+ products when requested information for conducting investigation is provided.

• Brand Name: REVANESSE
• Type of Device: REVANESSE
• 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 Key: 14836052
• MDR Text Key: 295070693
• Report Number: 3004423487-2022-00028
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P160042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 06/27/2022

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/27/2022
• 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 Sex: Female