MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ 1.2 ML

Device Problem Output Problem (3005)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/08/2022

Event Type  Injury  

Event Description

Based on the information provided, the patient got injected with revanesse versa+ dermal fillers in the chin area of the patient approximately on (b)(6) 2022. The lot of the product injected was not provided and, therefore, not verified. Amount of product injected was not specified. According to the initial communication, 45 mins after the initial treatment with revanesse versa+ dermal filler injector has recognized symptoms of a possible vascular occlusion in the chin during another procedure. Cap refill was recording at 12 seconds and intervals of a little longer, skin was greying and symptoms were climbing. Injector has immediately followed the vascular occlusion protocol, provided the patient with an aspirin and immediately began to flood the area with hyaluronidase and massage. Injector was able to reverse the possible vascular occlusion in approximately 45 mins and observed the patient following treatment. Injector has stated cap refill returned to normal and the colour of the skin was normalised. Patient went home. Injector continued following up with the patient throughout the night and following day. 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. From the day of notification, qa department at prollenium medical technologies contacted clinic/injector requesting information regarding this clinical complaint, no response from the injector/clinic has been received. On (b)(6) 2022, injector informed the qa department at prollenium medical technologies that requested information for full investigation will be provided within a month. 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. Status of the patient was described as happy. 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+ products when requested information for conducting investigation is provided.

• Brand Name: REVANESSE VERSA+ 1.2 ML
• Type of Device: REVANESSE 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 Key: 13712955
• MDR Text Key: 287181942
• Report Number: 3004423487-2022-00009
• 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

• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• 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