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  

Manufacturer Narrative

Manufacturer narrative: lot number was not reported.Pharmacovigilance comment: the serious event of abscess and the non-serious events of implant site pustule and foreign body reaction were considered expected and possibly related to the treatment.Serious criteria include the need for medical intervention to prevent permanent damage including incision and drainage of the abscess.The non-serious event of possible cryptococcal cutaneous infection was considered unexpected and possibly related to the treatment.Potential etiologies for the reported events include microbial contamination and opportunistic infection.Potential contributory factors include inadequate aseptic, injection or post treatment techniques, immunodeficiency secondary to etanercept therapy and medical history, and inflammatory reaction secondary to the infection.The case meets the seriousness criteria for expedited reporting to the regulatory authorities.Capa comment: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 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 had left parotidectomy in the past.The patient had no known allergies.Concomitant treatments included etanercept [etanercept], synthroid [synthroid], sertraline [sertraline] and omeprazole [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
• Manufacturer (Section G): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• Manufacturer Contact: amy poteate ; 14501 north freeway; fort worth, TX 76177 ; 8175615353
• MDR Report Key: 8780596
• MDR Text Key: 150831734
• Report Number: 9710154-2019-00070
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024/S073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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
• Date Manufacturer Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR