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

Lot Number UNKNOWN

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

Patient Problems Erythema (1840); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of mass at implant site, the non-serious events of erythema implant site and dryness at injection site were considered expected and possibly related to the treatment.Serious criteria include the need for medical interventions and long standing event suggestive of permanent damage.The potential root cause is the treatment procedure and a more specific cause cannot be established based on the available information.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacturer narrative: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a nonconforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 14-apr-2021 by a (b)(6)-year-old female patient, reporting her own case.Additional information was received on 15-apr-2021 from patient herself.The patient's medical history included depression and sulfur allergies.The patient had previously received treatment with restylane and botox.Concomitant treatments included sertraline [sertraline] and bupropion [bupropion].It was unknown if patient had any other vaccines, illnesses or dental procedures in previous 6-12 months.On an unknown date in 2018, the patient received treatment with restylane defyne (unknown amount, lot number, injection technique and needle type) to nasolabial folds and above top lip.A month later, on an unknown date, the patient experienced hard lumps/bumpy(implant site mass), red(implant site erythema) and dry areas(injection site dryness) along the nasolabial folds and just under nose.The patient had tried herbs and lavender oil as corrective treatment.The hcp attempted to dissolve product with hyaluronidase [hyaluronidase] in 2019.On an unknown date in (b)(6) 2021, the patient received first dose of pfizer covid-19 vaccine.On (b)(6) 2021, the patient received second dose of pfizer covid-19 vaccine.On an unknown date in (b)(6) 2021, the hcp made another attempt to dissolve product with hyaluronidase, without improvement.The dermatologist was consulted who advised the use of steroids but it was refused by the patient.Outcome at the time of the report: hard lumps/bumpy was not recovered/not resolved.Red was not recovered/not resolved.Dry areas was not recovered/not resolved.

• Brand Name: RESTYLANE DEFYNE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 11789832
• MDR Text Key: 249453418
• Report Number: 1000118068-2021-00013
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2021
• Distributor Facility Aware Date: 04/14/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BUPROPION; SERTRALINE
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 67 YR