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

Lot Number 18668

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

Patient Problems Pain (1994); Obstruction/Occlusion (2422); Easy Bruising (4558); Swelling/ Edema (4577)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of vascular occlusion and the non-serious events of swelling, bruising and pain at implant site were considered expected and possibly related to the treatment.Serious criteria include the need for medical interventions to prevent permanent damage.The likely root cause include intravascular filler injection leading to vascular occlusion.Potential contributory factor for bruising and pain at implant site include hylenex injection.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 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 26-may-2021 by an other health professional which refers to a (b)(6) female patient.Additional information was received on 27-may-2021 from same reporter.The patient's medical history included hair loss.The patient had not received any fillers or toxins in the past.No information about history of allergies has been provided.Concomitant treatments included doxycycline [doxycycline] for hair loss.On an unknown date in (b)(6) 2021, the patient had received first dose of pfizer covid-19 vaccine.On (b)(6) 2021, the patient had received second dose of pfizer covid-19 vaccine the patient had not received any other vaccine or dental procedures in the past 6-12 months and did not had any illness the month prior to the injection.On (b)(6) 2021, the patient received treatment with 1.6 ml restylane kysse (lot 18668), 0.2 ml each to right and left bottom lip, 0.6 ml to right upper lip, 0.4 ml to left upper lip and 0.1 ml to mid lip of both sides using an unknown needle type and injection technique.Same day, on (b)(6) 2021, the patient experienced swelling (implant site swelling) and occlusion(vascular occlusion) to left upper lip at the end of second syringe of restylane kysse.As a corrective treatment, the hcp had injected 4 vials of hylenex [hyaluronidase] to the left upper lip.The occlusion and swelling were resolved on the same day.After the patient's injection with hylenex on (b)(6) 2021, the patient experienced bruising(implant site bruising) and soreness(implant site pain) to the upper lip which were still there.On (b)(6) 2021, hcp injected 2 vials hylenex to right upper lip and lower lip.Outcome at the time of the report: occlusion was recovered/resolved.Swollen was recovered/resolved.Bruising was not recovered/not resolved.Soreness was not recovered/not resolved.

• Brand Name: RESTYLANE KYSSE
• 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: 11978819
• MDR Text Key: 268666518
• Report Number: 1000118068-2021-00016
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/10/2021

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 Expiration Date: 09/30/2022
• Device Lot Number: 18668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2021
• Distributor Facility Aware Date: 05/26/2021
• Event Location: Other
• Date Report to Manufacturer: 05/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR