MAUDE Adverse Event Report: GALDERMA Q-MED UNSPECIFIED PLLA FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE

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

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Event Description

Case reference number (b)(4) is a literature report detected on 01-oct-2019 by medical affairs department during a literature screening.This case was identified from the literature article beer k.Clinicopathologic correlation of delayed-onset periorbital poly-l-lactic acid nodules.Dermatol surg 2009; 35:399-402.A (b)(6)-year-old female patient was evaluated for cosmetic treatment of her periorbital areas.Examination revealed deep tear troughs and some mild photo damage.There was not a significant degree of skin laxity, fat pad herniation, or lid laxity.Options that were discussed included laser resurfacing using a fractional laser device, injection of hyaluronic acid fillers, and collagen stimulation using plla.Autologous fat was not considered because it was thought to be too unpredictable in this location.Calcium hydroxylapatite was not thought to be the treatment of choice because of its opaque nature.Hyaluronic acids were strongly considered because they offer a variety of viscosities, particle sizes, and concentrations.Additionally, they offer the ability to be reversed with hyaluronidase in the event that the patient is not pleased with the outcome of treatments.However, she desired a treatment that would be more long lived than those offered by the hyalurons.Plla was considered to be an ideal material for this patient.The patient was treated with two sessions of injections at an interval of 4 weeks.Dilution of the product was conducted using 4ml of sterile water and 2ml of 1% lidocaine with 1:100,000 epinephrine.Reconstitution of the product had been more than 24 hours before injection, and the product was allowed to warm to room temperature.Each treatment session involved one bottle of material, and injections were at the level of the periosteum.Depot injections of approximately 2ml into each tear trough were made at the level of the periosteum, and deep massage was performed after injections, with instructions given to the patient to repeat the massage for 5 minutes per day five times for 5 days.Approximately 1 year after injection, the patient presented for evaluation of subcutaneous papules that was clearly visible and approximately 4 mm in size.To remove the largest of these, surgical excision was undertaken using a 3-mm incision, and extraction of the nodule was accomplished using forceps and dissecting scissors.Histopathology revealed a foreign body reaction with a well-circumscribed lesion.Under the microscope, it was obvious that the placement of the nodule was periosteal because there was muscle tissue superficial to the granuloma.Low-power (x 40) view of the subcutaneous nodule.The orbicularis muscle was evident.The granuloma was of a foreign body type with flecks of poly-l-lactic acid evident.Higher power (x 20) revealed extensive collagen production, with foreign body granulomas evident.Higher power (x 100) demonstrates the new collagen formation that surrounds the foreign body granulomas.A 40 view of the granuloma demonstrated sequestration and collagen formation around what appeared to be flakes of plla.At x 400, the foreign body reaction was evident, as the surrounding collagen created in response.

• Brand Name: UNSPECIFIED PLLA FILLER
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• MDR Report Key: 9708007
• MDR Text Key: 189612254
• Report Number: 1000118068-2020-00013
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2020,02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2020
• Distributor Facility Aware Date: 02/12/2020
• Date Report to Manufacturer: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR