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

Lot Number 18079

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

Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Pallor (2468); Vascular System (Circulation), Impaired (2572)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious expected event of vascular occlusion was considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions.The non-serious expected events of pain and pallor at implant site were considered possibly related to the treatment.Potential contributory factor include intravascular filler injection leading to vascular occlusion and manifestations of ischaemia.The unexpected event of drug hypersensitivity, and the expected events of pruritus at implant site and angioedema were considered unrelated to the treatment.Alternative etiologies for lip swelling and pruritus include allergic reaction to hylenex.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering narrative: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.Manufacturing narrative: the reported lot number was valid.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2020 by a physician which refers to a (b)(6) year-old (b)(6) american female patient.This case contains additional information received on 26-jun-2020 from the same physician.The patient had fitzpatrick skin type iii-iv.The patient had no known medical history or allergies.The patient was taking no routine medications.The patient had not received any fillers or toxins in the past.On (b)(6) 2020, the patient received treatment with 1 ml restylane kysse (lot 18079), 0.6 ml to upper and 0.4 ml to lower lip with needle that came along with package using unknown injection technique.Same day, on (b)(6) 2020, after her injection at night, the patient had experienced pain(implant site pain) in lips more than normal.2 days later, on (b)(6) 2020, the patient experienced white patchy skin changes(implant site pallor) at face, cheek and lip.3 days later, on (b)(6) 2020, the patient developed a vascular occlusion(vascular occlusion) to right upper lip.The patient was asked to come in for an injection of hylenex.On (b)(6) 2002, patient contacted her hcp and hcp injected hylenex [hyaluronidase].The patient developed an allergic reaction to the hylenex (drug hypersensitivity).The patient also experienced swelling/angioedema in lip(angioedema) and itchy(implant site pruritus).On (b)(6) 2020, the patient was prescribed with benadryl [diphenhydramine hydrochloride] 50 mg qd, prednisone [prednisone] 60 mg qd, doxycycline [doxycycline] 100 mg twice a day, aspirin [acetylsalicylic acid] 325 mg qd, priolesec [omeprazole], tobradex [tobramycin] ointment, pepcid [famotidine] 25 mg qd for treatment.Currently still treating.On (b)(6) 2020, itchiness was resolved but the pain, the vascular occlusion and swelling were still there.Outcome at the time of the report: vascular occlusion was not recovered/not resolved.Pain was recovered/resolved.White patchy skin changes was not recovered/not resolved.Allergic reaction to the hylenex was unknown.Swelling/angioedema in lip was not recovered/not resolved.Itchy was recovered/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
• 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 ; 9615146
• MDR Report Key: 10241573
• MDR Text Key: 197925430
• Report Number: 9710154-2020-00060
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140029/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Lot Number: 18079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR