MAUDE Adverse Event Report: GALDERMA Q-MED RESTYLANE LYFT WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

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

Patient Problems Abscess (1690); Foreign Body Reaction (1868); Unspecified Infection (1930); No Code Available (3191)

Event Date 04/24/2019

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on 09-may-2019 by a physician which refers to a (b)(6) year-old caucasian female patient.The patient medical history included psoriasis, hypothyroidism.The patient had left parotidectomy in the past.The patient had no known allergies.Concomitant treatments included etanercept [etanercept], synthroid [synthroid], sertraline and omeprazole.The patient had previously received treatment with unspecified fillers in the past.On (b)(6) 2019, the patient received treatment with 3 ml restylane lyft with lidocaine with 29 gauge needle (unknown lot number and injection technique) into left cheek for the indication of defect/concavity from parotid surgery) and in the left lateral mid face.23 days later, on (b)(6) 2019, the patient experienced pustule on the left cheek (implant site pustules).It was reported that 5 ml was drained and cultured which did not show any growth.27 days later, on (b)(6) 2019, the patient experienced enormous abcess on the left cheek (implant site abscess).20 ml of pus was drained, cultured and also sent to a medical center for pathological examination which suggested multiple histiocytes foreign body reaction (foreign body reaction) and questionable cryptococcus liquifaciens (cryptococcal cutaneous infection).The patient was treated with incision and drainage through skin and packing.The patient was improving.The reporter assessed the case as serious due to the intervention with i&d of the abscess.Outcome at the time of the report: pustule left cheek was recovering/resolving.Abcess left cheek was recovering/resolving.Suggests multiple histiocytes foreign body reaction was recovering/resolving.Questionable cryptococcus liquifaciens was recovering/resolving.Tracking list: v.0 initial- v.1 fu received on 14-jun-2019.Suspect device details including volume, implant date, site and needle type was updated.Case upgraded to serious based on the information received on 14-jun-2019.

• Brand Name: RESTYLANE LYFT WITH LIDOCAINE
• 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: 8780600
• MDR Text Key: 150704802
• Report Number: 1000118068-2019-00004
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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: 07/11/2019
• Distributor Facility Aware Date: 06/14/2019
• Event Location: Other
• Date Report to Manufacturer: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ETANERCEPT; OMEPRAZOLE; SERTRALINE; SYNTHROID
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR