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 Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/17/2021

Event Type  Injury  

Event Description

Based on the information provided, the patient got injected with 1.2 ml of revanesse lips+ (with lidocaine) into the lips area of the patient on (b)(6) 2021.Patient is (b)(6) female caucasian.According to the injector, the patient has been previously treated with dermal fillers for the last 12 years without issue.According to the injector, patient takes lexapro and xanax regularly.Patient was encouraged to apply ice and take an antihistamine.Patient was informed that an anti-inflammatory could be taken but would risk bruising.Blt cream was used as topical anaesthetic.No known drug allergies reported.No allergies to dermal filler reported.No elevated fitzpatrick scale reported.No medications after or before the treatment provided.No pre-existing risk factors reported.The medical director of the clinic has been notified of this adverse event.As per information provided, patient presented with white spots on her lips after treatment.Injector does not believe it is a vascular occlusion after six months without necrosis and it's most likely sebaceous glands.Patient requested that the injector consult with the pmt medical director and explain why she has white spots in her upper and lower lips.She indicated that she had lip fillers for the last 12 years and never had this issue before.As of feb 1, 2022, current status of the patient can be described as "no more follow up needed".

Manufacturer Narrative

The clinical complaint has been adequately investigated.The lot number has been verified and has been confirmed to be released by the company.It has been confirmed that no 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 was provided to the clinic along with the letter indicating approved areas for injection for revanesse lips+ product: "the following is a clinical opinion based on the information provided below; on (b)(6), 2021 the patient had 1.2 mls of revanesse lips+ injected into her lips.The exact location of these injections was not provided.Blt anesthetic cream was applied prior to injection.There were no adverse events or concerns at the time of injection.Some time later ( ? months) the patient contacted the injecting physician because she became aware of "white spots on her lower lip".The treating physician diagnosed these as sebaceous glands.There were no signs or symptoms of an adverse event related to the injection.The patient requested that the physician consult with prollenium's medical director so an adverse event report was filed with the company.There is no available before photos.There were two after photos provided.One photo shows a few classic fordyce ( sebaceous ) glands on the lower central lip.The other photo does not show these glands.Neither photo shows clinical signs of lumps, nodules or any defined adverse injection events.Fordyce spots ( glands) are a normal and harmless condition that are felt to be present in 70-80% of adults.They are caused by elevated cholesterol, increasing age and excess sebum production ( oily skin).They can be exacerbated by stress, hormones or anything which blocks the sebaceous ducts, such as lipstick, topical products or excess dry or dead skin.They require no treatment and usually fade with time.My clinical opinion is that this case does not represent an adverse event but rather a normal physiologic event.I trust this opinion will be of value to all parties concerned.".

• 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: 13656361
• MDR Text Key: 289956226
• Report Number: 3004423487-2022-00007
• 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: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/02/2022

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: 06/18/2023
• Device Model Number: 40149
• Device Lot Number: 21G167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White