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

Lot Number 17763

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

Patient Problems Obstruction/Occlusion (2422); Pallor (2468); Easy Bruising (4558)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious event of vascular occlusion and the non-serious events of pallor and bruising at implant site were considered expected and possibly related to the treatment.Serious criteria include the need for medical intervention with multiple hyaluronidase treatments to prevent permanent damage.The likely root cause include intravascular filler injection leading to vascular occlusion.Potential contributory factor for bruising at implant site include multiple injections with hyaluronidase.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.The reported lot number was valid and verified the reported product.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

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2021 by another health professional which refers to a (b)(6) female patient.The patient's medical history included gastric bypass and rheumatoid arthritis.The patient had no known drug allergies.Concomitant treatments included multivitamin [multivitamin] daily.No information about previous filler treatments has been provided.The hcp reported that the patient not had any dental procedures in the last 4 weeks and hcp does not know if patient had any other vaccinations or any illness or sickness leading up to injection date.On an unknown date, the patient had received first dose of unspecified covid vaccine.On an unknown date in (b)(6) 2021 (almost exactly 4 weeks prior to the injection), the patient had received second dose of unspecified covid vaccine.On (b)(6) 2021, the patient was pre-medicated with lidocaine with epi.On (b)(6) 2021, the patient received treatment with 1 ml restylane lyft with lidocaine (lot 17763) to cheeks using an unspecified cannula with unknown injection technique.The patient also received treatment with radiesse to lower half of the face and 168 units of dysport [dysport] on the same day.Same day, on (b)(6) 2021, while hcp injecting around 0.25 ml of restylane lyft with lidocaine in the right cheek area, she noticed that the area was blanched(implant site pallor).The hcp immediately withdrew the injection and applied warm compresses to the area.Hcp reported that the patient was experiencing a vascular occlusion(vascular occlusion).The hcp injected 5 vials of hylenex [hylenex] into the area.The patient also experienced bruising(implant site bruising) which eventually resolved.Outcome at the time of the report: blanched was recovered/resolved.Vascular occlusion was recovered/resolved.Bruising was recovered/resolved.

• 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
• 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: 11592279
• MDR Text Key: 260634525
• Report Number: 9710154-2021-00020
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/30/2021

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: No Information
• Device Expiration Date: 09/22/2022
• Device Lot Number: 17763
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 03/30/2021
• 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
• Patient Age: 51 YR