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

Lot Number 16619-1

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

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/08/2019

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2019 by a consumer or other non health professional which refers to a (b)(6) female patient. Additional information was received on (b)(6) 2019 from same reporter. The patient's medical history included allergic condition and pollinosis. The patient had never received any treatment with dermal fillers, skin boosters or botox. Concomitant medications included cardiomagnyl [acetylsalicylic acid, magnesium hydroxide] 75 mg 1 tablet daily for cardiovascular disease prevention. On (b)(6) 2019, the patient received treatment with 2 ml restylane volyme (16570-1), 1 ml each to mid face and cheeks, deep dermal implantation, using unknown injection technique and needle type for enhancing volume of cheek areas and mid face. On (b)(6) 2019, the patient received treatment with 2 ml restylane lyft lidocaine (16619-1), 1 ml each to mid face and cheeks, supra periosteal implantation using unknown injection technique and needle type for correction of moderate to severe facial wrinkles and mid face enhancement. On (b)(6) 2019, in the morning, the patient had experienced moderate swelling/small size fluid accumulation (implant site oedema), redness (implant site erythema) and pain (implant site pain) on the right cheek. The patient started receiving treatment with rocephin [ceftriaxone sodium] 1 gram, intramuscular, two times a day for 7 days from (b)(6) 2019 and reparil-gel [diethylamine salicylate, escin] 1 times per day topically from (b)(6) 2019. The patient also received dexamethasone [dexamethasone] im and iv for 7 days, 16 mg/day 1, 12 mg/day 2, 8 mg/day 3 and 4 mg/day 4. After that patient was prescribed with dexamethasone plus physiological solution [sodium chloride] for iv infusion for 3 days 8 mg/day 1, 8 mg/day 2 and 4 mg/day 3 from (b)(6) 2019. The patient was also topically treated with levomecol [chloramphenicol, methyluracil] ointment 2 times per day for 3 days, heparin [heparin] ointment 2 times per day for 3 days, laticort [hydrocortisone butyrate] ointment 1 times per day before sleep for 3 days and cetaphil gentle skin cleanser for daily use. On an unknown date in (b)(6) 2019, the patient underwent soft tissue ultrasonic examination which revealed no tissue abnormalities, but subcutaneously expressed a small size fluid accumulation on the lower projection of right cheek (5x4 mm). The body temperature was normal (36. 7 degree celsius) all that time. The events were more or less responsive to anti-inflammatory treatment, symptoms partially regressed. As soon as the treatment was discontinued, events such as redness and swelling developed again on (b)(6) 2019. On (b)(6) 2019, the filler was dissolved with hyaluronidase [hyaluronidase]. Despite dissolution of restylane, the patient still had sensation of pain. The patient noted that while touching the skin in projection, she had discomfort (injection site discomfort) and slight pain where the fillers were located. Since the patient was extremely worried and felt very emotional, she had consulted different physicians (especially head and neck surgeons) to figure out what was going on. The physicians assured her that after hyaluronidase injection, it might take approximately two weeks to month to resolve skin irritation (implant site irritation) and swelling, as it was widely recognized by practitioners. Outcome at the time of the report: swelling/small size fluid accumulation was not recovered/not resolved/ongoing. Redness was not recovered/not resolved/ongoing. Pain was not recovered/not resolved/ongoing. Discomfort was not recovered/not resolved/ongoing. Irritation was not recovered/not resolved/ongoing.

Manufacturer Narrative

Company comment: the serious event of oedema at implant site was considered possibly related to the treatments. Seriousness criteria include the need for multiple medical interventions to prevent the permanent damage. The non-serious events of erythema, pain and irritation at implant site and discomfort at injection site were considered possibly related to the treatments. The potential root cause include treatment procedure. 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. 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.

• Brand Name: RESTYLANE LYFT 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 north freeway; fort worth, TX 76177
• MDR Report Key: 12883708
• MDR Text Key: 282971057
• Report Number: 9710154-2021-00074
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: GG
• PMA/PMN Number: P040024/S073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2020
• Device Lot Number: 16619-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• 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: Unkown

Patient Treatment Data

Date Received: 11/29/2021 Patient Sequence Number: 1

Treatment

CARDIOMAGNYL; RESTYLANE VOLYME