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 woman was evaluated for facial rejuvenation.Her specific goals included treatment of mid-face descent and correction of the deep tear troughs that had developed over the previous few years.Her past injection history was notable for injections with numerous hyaluronic acids and calcium hydroxylapatite, without any complications, but she desired a more durable correction and was offered treatment with plla.The patient was injected with plla diluted with 4ml of sterile water and 2ml of 1 percent lidocaine with 1:100,000 epinephrine that had been allowed to imbibe for more than 24 hours.One bottle of product was injected into her cheeks, tear troughs, and zygomatic arch areas.The amount injected into the tear trough area was approximately 1ml on each side.A depot injection technique at the periosteal level was used, with deep massage performed after injection.The patient had a repeat injection of product approximately 1 month after her first injection, using an identical protocol.The patient noted substantial improvement of her face and was pleased with her appearance.Eighteen months after her last injection, the patient presented for evaluation of lumps on her face.One of these, located on her left inferior orbital rim, was surgically excised to ensure that it was not a subcutaneous neoplasm.Histopathologic evaluation revealed a dense foreign body granuloma reaction with abundant formation of collagen.Corrective treatment included injections of triamcinolone acetonide 10 mg/ml, with gradual improvement noted after two injections.

• 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: 9707990
• MDR Text Key: 189612882
• Report Number: 1000118068-2020-00012
• 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: 59 YR