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

Model Number 40149

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

Patient Problems Erythema (1840); Nodule (4551); Swelling/ Edema (4577)

Event Date 03/22/2022

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 no other clinical complaint has been found for the particular lot number in question.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 lips+ product when requested information for conducting investigation is provided.

Event Description

Based on the information provided, the patient was injected with revanesse lips+ (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 (b)(6) at the moment of the initial report.Date of birth: (b)(6).According to the initial report, the patient was experiencing swelling, redness, nodules.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 29 apr 2022, qa department at prollenium medical technologies contacted clinic/injector requesting information regarding this clinical complaint.On 24 may 2022, as a result of no response, qa department at prollenium medical technologies contacted clinic/injector again requesting information regarding this clinical complaint.As of 24 may 2022, qa department at prollenium medical technologies received no response.The qa department will continue the investigation.

• Brand Name: REVANESSE LIPS+ 1.2 ML
• Type of Device: REVANESSE LIPS+
• 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: 14492916
• MDR Text Key: 292577884
• Report Number: 3004423487-2022-00023
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10669808003032
• UDI-Public: 10669808003032
• 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 Practitioner
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/24/2022

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
• Device Expiration Date: 10/22/2023
• Device Model Number: 40149
• Device Lot Number: 21K058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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: 47 YR
• Patient Sex: Female