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

Lot Number UNKNOWN

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

Patient Problems Cellulitis (1768); Deformity/ Disfigurement (2360)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious expected events of mycobacterial infection, staphylococcal infection and cutaneous contour deformity were considered possibly related to the treatment.Seriousness criteria include the need for medical and surgical interventions and permanent damage.The potential root cause include injection procedure associated with inadequate aseptic technique.Potential contributory factor for cutaneous contour deformity include surgeries.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: 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.A follow-up on the lot number will be performed.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.

Event Description

(b)(4) is a spontaneous report sent on 05-oct-2021 by an adult female patient via attorney, concerning herself.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2019, the patient received treatment with restylane lyft with lidocaine to right cheek (unknown amount, lot number, injection technique and needle type).On (b)(6) 2019, the patient was infected with mycobacterium spp (mycobacterium neoaurum) (mycobacterial infection) and infected with rare staphylococcus epidermidis group (staphylococcal infection) that appears to be centered on the filler injection site, requiring surgeries, permanent disfigurement (cutaneous contour deformity) and related damages.The patient was treated with hyaluronidase [hyaluronidase] on (b)(6) 2019 and (b)(6) 2019 as a corrective treatment.Outcome at the time of the report: infected with mycobacterium spp (mycobacterium neoaurum) was unknown infected with rare staphylococcus epidermidis group was unknown.Permanent disfigurement was not recovered/not resolved/ongoing.

• Brand Name: RESTYLANE LYFT WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 12732483
• MDR Text Key: 282834303
• Report Number: 9710154-2021-00067
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P040024/S073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability