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

Lot Number 16929

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious expected event of infection at implant site and the non-serious expected events of oedema, pain, erythema, warmth, induration at implant site and unexpected event of flushing were considered possibly related to the treatments.Serious criteria include the need for multiple medical interventions, and hospitalization.Potential route causes for the reported events include the user error of inadequate aseptic technique, microbial contamination, or biofilm of the device, or underlying patient predisposition for bacterial seeding of the implant, e.G.From poor dental hygiene, interactions with preexisting treatments, or inadequate postprocedural face care regimen.The restylane fynesse and restylane kysse treatments were limited to the mouth and lips, respectively, and were therefore, not considered likely to contribute to the infections in the infraorbital region.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: 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.Manufacturer narrative: lot number was not reported.

Event Description

Case reference number: (b)(4) is a spontaneous report sent on 04-dec-2020 by a dentist, which refers to a female patient of an unknown age.No information about medical history, history of allergies, or previous filler treatments has been provided.Concomitant treatments included dysport [dysport] for unknown indication in 2020.On (b)(6) 2020, the patient received treatment with sculptra (unknown amount, lot number, injection technique and needle type) to zygomatic region in periosteum/supraperiosteal and malar region for unknown indication.The same day, patient also received treatment with restylane lidocaine (lot 16929), 0.3 ml on each side to the dark circles region/tear trough, 1 ml restylane kysse (lot s2193290006) to lips and 1 ml restylane fynesse (lot s2193290005) to orbicularis oris region/perioral region with unknown needle type and injection technique for an unknown indication.2 days later, on (b)(6) 2020, the patient experienced mild infraorbital edema/swelling(implant site oedema) in the left eye region.As a treatment, the patient received decadron [dexamethasone] at a dose 4 mg every 12 hours for five days.After that, there was a regression of the edema becoming very subtle.About 10 days later, the patient experienced edema again.According the reporter the edema returned very fast and started to increase a lot.The patient guided to receive lymphatic drainage on face.On unknown date in (b)(6) 2020, patient received treatment with hyaluronidase 150 tru and the edema started to improve.On unknown date in (b)(6) 2020, the patient was treated with cephalexin [cefalexin] 500 mg as prophylactic use with suspected infection (implant site infection), and an immediate improvement was noted.But after some hours the edema returned, much worse and patients was eye completely closed.On unknown date in (b)(6) 2020, the patient was referred to a hospital and remained there for approximately 6 hours, but she did not receive the correct care, was not medicated.The patient underwent to a tomography and no changes were showed.After 6 hours, the patient received treatment with cephalosporin and hydrocortisone via intravenous route and transferred by ambulance to another hospital.On an unknown date in (b)(6) 2020, the patient was discharged from other hospital and prescribed cephalexin 500 mg orally for 10 days, prednisolone for 5 days and deocil, ketorolac tromethamine, for pain.The patient's clinical condition had regressed and started to improve one hour later.On the other day in (b)(6) 2020, the patient had improved considerably and returned to her normal routine.It was noticed a more rigid volume located/hardened(implant site induration) with flushing, and mild pain (implant site pain), and she noticed to be supported on premaxilla bone.10 days later, after stopped using the antibiotic, patient started experiencing edema on the other side, on the right eye, which had not been affected.The hyaluronic acid was removed with hyaluronidase that controlled the progression and did not reach left eye level.According the reporter, the region was reddened/red (implant site erythema) and at the time of the report, the patient was normally closing her eyes.The reporter clarified that where it was hardened, in the piriform fossa region, neither sculptra nor the hyaluronic acid was injected and that the edema was located on the tear trough on (b)(6) 2020, one month later, the patient's condition started worsening again with edema in the left eye again, that became red and heat(implant site warmth).On (b)(6) 2020, as a treatment, the patient used prednisolone at 6 am.According the reporter, there were no systemic symptoms.Outcome at the time of the report: suspected infection was not recovered/not resolved.Edema/swelling was not recovered/not resolved.Pain was not recovered/not resolved.Reddened/red was not recovered/not resolved.Heat was not recovered/not resolved.Flushing was not recovered/not resolved.More rigid volume located/hardened was not recovered/not resolved.

• Brand Name: RESTYLANE 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: 11022995
• MDR Text Key: 223748019
• Report Number: 9710154-2020-00102
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P040024/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Lot Number: 16929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention