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

Lot Number UNKNOWN

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

Patient Problems Deformity/ Disfigurement (2360); Swelling/ Edema (4577)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of oedema at implant site and the non-serious event of cutaneous contour deformity were considered expected and [?]possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The potential root cause is the treatment procedure.Potential contributory factors for the cutaneous contour deformity include multiple hyaluronidase injections and for the persistent edema, the pixel and micro focused ultrasound sessions.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.A follow up to retrieve the lot number will be performed.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 01-jun-2021 by a physician which refers to a female patient of an unknown age.This was case 1 of 2.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On an unknown date in (b)(6) 2020, the patient received treatment with two syringes restylane lyft (unknown lot number) to malar region, in the periosteum and infraorbital areas (not in the lachrymal sulcus), middle/deep layer of unknown location for unknown indication using an unspecified needle with unknown injection technique.Unknown later, on an unknown date in (b)(6) 2020, the patient experienced persistent eyelids edema(implant site oedema).On unknown date between (b)(6) 2020 and (b)(6) 2020, the patient received a pixel and micro focused ultrasound sessions at the lower eyelids.On unknown date in (b)(6) 2021, the patient received treatment with hyaluronidase [hyaluronidase] at the lachrymal sulcus and infraorbital regions.After that, patient experienced a temporary improvement of persistent eyelids edema.On unknown date in (b)(6) 2021, the patient received treatment with hyaluronidase and prednisone [prednisone].After that, patient experienced again a temporary improvement of persistent eyelids edema.On unknown date in (b)(6) 2021, the patient received treatment with hyaluronidase, prednisone and tetralysal [lymecycline].After that, patient experienced an improvement of persistent eyelids edema.Unknown time later, on an unknown date in 2021, after the last hyaluronidase injection, the patent experienced an asymmetry(cutaneous contour deformity), the malar sustention on the right side was kept, but at the left side the product seems to be diluted by the hyaluronidase.On unknown date in (b)(6) 2021, the patient again received treatment with restylane lyft (unknown amount, lot number, injection technique and needle type) to left malar region (periosteum) for unknown indication.On an unknown date in 2021, after the second session of restylane lyft, the patient experienced lower eyelid/infraorbital edema.Outcome at the time of the report: edema was unknown.Asymmetry was unknown.

• Brand Name: RESTYLANE LYFT
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; RW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 11979590
• MDR Text Key: 267461426
• Report Number: 9710154-2021-00039
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P040024/S073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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