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

Model Number 40083

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

Patient Problem Swelling/ Edema (4577)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

The clinical complaint has been investigated.The lot number has been verified and has been confirmed to be released by the company.It has been confirmed that three other clinical complaints from same clinic were found associated with this lot number.The batch record, qc test reports, and training of staff were analysed and it has been determined that product is within required specifications, and manufactured according to appropriate procedures.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+ product when requested information for conducting investigation is provided.

Event Description

Based on the information provided, the patient was injected with revanesse versa+ (with lidocaine) in the lips area of the patient on (b)(6) 2022.Amount of product injected was 1.2 ml in the lips area of the patient, according to the initial report.Patient is female; age of the patient is unspecified.According to the initial report, the patient was experiencing nodules of the bottom left lip.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.On 14 mar 2022, shortly after day of notification, the qa department at prollenium medical technologies contacted clinic/injector requesting information regarding this clinical complaint.On 25 mar 2022, as a result of no response, qa department at prollenium medical technologies contacted clinic/injector again requesting information regarding this clinical complaint.On 26 mar 2022, the medical director of the clinic informed the qa department at prollenium medical technologies that requested information will be provided.On 28 mar 2022, qa department at prollenium medical technologies contacted clinic/injector again requesting information regarding this clinical complaint.On 07 apr 2022, qa department at prollenium medical technologies contacted clinic/injector again requesting information regarding this clinical complaint.No response as of 07 apr 2022 has been received.The qa department will continue the investigation.

Event Description

Based on the follow-up information provided, the patient was injected with revanesse versa+ (with lidocaine) in the upper and lower lips area of the patient on (b)(6) 2022.Amount of product injected was 1.2 ml in the upper and lower lips area of the patient, according to the initial report.Patient is female, latino; age of the patient is 25.Date of birth is unspecified.According to the initial report, the patient was experiencing nodules of the bottom left lip.No other symptoms reported.No medications given after or before the treatment.Patient was given cold compress and hyaluronidase.As reported, the patient does not have pre-existing risk factors.Patient has lupus diagnosis no covid vaccine reported.Elevated fitzpatrick scale: 5.No topical anaesthetic used during the procedure.No allergies to dermal fillers reported.First time dermal filler treatment.Medical director of the clinic has been informed of this adverse event.Current status of the patient: nodules resolved, patient is happy.

Manufacturer Narrative

The clinical complaint has been investigated.The lot number has been verified and has been confirmed to be released by the company.It has been confirmed that three other clinical complaints from same clinic were found associated with this lot number.The batch record, qc test reports, and training of staff were analysed and it has been determined that product is within required specifications, and manufactured according to appropriate procedures.Prollenium medical technologies' medical director's response to this adverse event to be provided to the clinic along with the letter indicating approved areas for injection for revanesse versa+ product: "the following is a clinical opinion based the information and photos provided by the clinic: between (b)(6), 2022 there were 4 patients injected with revanesse versa 1.2 mls into their lips.The history states all four patients had "nodules" which were treated with cold compresses and hyaluronidase with complete resolution.All 4 after photos showed asymmetric superficial filler deposition which i assume are the areas described as "nodules".There are no dates on the after photos however based on the environment, clothing and presence of needle marks and bruises it is assumed there were taken shortly after injection.Nodules are firm, small (> 1 cm) lumps at the sites of injections.They typically occur when too much product is injected too superficially in highly mobile areas.Nodules typically do not develop for 6-8 weeks as the firmness represents the bodies' inflammatory reaction to the deposited filler.Based on the photos, the onset and the quick and complete resolution of the lumps, my clinical opinion is that these cases do not represent nodules but rather suboptimal deposition of product in the lips related to technique.As there is a trend to overfill the lips with deposition of " ha struts" in the body of the lip it is important to avoid superficial injections and to massage the regions post injection.It is reassuring that all of these patients had their issues quickly and completely treated.I hope this clinical opinion is of value to all parties concerned.".

• 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: 14059040
• MDR Text Key: 288976711
• Report Number: 3004423487-2022-00015
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10669808001038
• UDI-Public: 10669808001038
• Combination Product (y/n): N
• PMA/PMN Number: P160042 S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: 40083
• Device Lot Number: 20K098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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 Age: 25 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic