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

Lot Number 17248-1

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

Patient Problems Purulent Discharge (1812); Erythema (1840); Extravasation (1842); Nodule (4551); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance: the serious expected event of purulent discharge and non-serious expected events of oedema, pain, erythema, nodule at implant site and unexpected event of extravasation at implant site were considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions and surgical drainage.The likely root cause is injection without following aseptic techniques.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: the reported lot number was valid.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to galderma quality management system.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 03-nov-2020 by a physician which refers to a (b)(6)-year-old healthy female patient.Additional information was received on 04-nov-2020 from the same physician.The patient's medical history included mild arrhythmia with an unspecified antiarrhythmic [antiarrhythmic agents] for years.No information about history of allergies has been provided.The patient had previously received treatment with an unspecified ha filler (an other brand), years ago, uneventfully.On 22-sep-2020, the patient received treatment with 1 ml restylane (lot 17248-1) for nasolabial sulcus filling using cannula 22g with unknown injection technique.The procedure was performed with adequate local asepsis, and all the hygiene care as recommended, without contacting the cannula with other surfaces, in the subcutaneous plane.In the first moment, the procedure occurred without intercurrences.Unknown time later, on an unknown date in (b)(6) 2020, the patient experienced local edema/swelling(implant site oedema) and mild pain(implant site pain).The patient had reported the events to the physician 5 days after restylane injection.On an unknown date in 2020, the patient returned to medical consultation, noticed no signs of tissue suffering, but local edema and mild erythema(implant site erythema) along the sulcus.On an unknown date in 2020, as a corrective treatment, the patient received prednisone [prednisone] 40 mg daily.72 hours after starting treatment, the patient was reassessed, and the local edema persisted with slight improvement.On an unknown date in 2020, patient started receiving ciprofloxacin [ciprofloxacin] 500 mg every 12 hours.5 days later, on an unknown date in 2020, patient was still experiencing edema, palpable nodulation/nodular regions(implant site nodule) with signs of fluctuations in some points.On an unknown date in 2020, then patient received treatment with hyaluronidase [hyaluronidase] in all regions where the restylane was injected.3 days later, the patient was reassessed, and received treatment with hyaluronidase again, in some points where the product was not completely dissolved.On an unknown date in 2020, the patient started receiving clindamycin [clindamycin] every 12 hours.7 days later, patient informed the reporter that in the region that had improved, returned experiencing swelling and there were signs of collection(implant site extravasation) on that site.On an unknown date in 2020, drained a small amount of secretion at the region and sent to culture test, and after a few days the result was negative.The reporter decided to change the antibiotic treatment and patient received minocycline [minocycline]100mg every 12 hours.A local ultrasound was requested and a small amount of purulent secretion(purulent discharge) was drained again and sent to culture test.On an unknown date in 2020, the patient returned to medical consultation with partial improvement of the clinical condition, but she was experiencing nodular regions at 3 points.On (b)(6) 2020, the patient underwent ultrasound scan and noted a badly delimited collection, with an estimated volume of 0.25 ml with fine deep debris to the zygomatic muscle and one collection of 0.2 ml to the right and another of 0.1 ml on left, suggesting ultrasound control (which she would undergo on 06-nov-2020).On an unknown date in 2020, the patient started receiving clarithromycin [clarithromycin] 500 mg every 12 hours along with minocycline treatment.The patient had a partial improvement of her clinical condition and she was being followed at the physician's office every 3 days.As per information received on 04-nov-2020, the physician informed that patient persisted experiencing the adverse events, with secretion output on the right side, with improvement on the left side.Patient was being evaluated by the reporter daily.The events had been lasting for one month and a half.The patient was still receiving treatment with minocycline and clarithromycin.Reporter assessed the severity as moderate/serious and causality as no definite cause.Hospitalization due the adverse events was denied.Outcome at the time of the report: purulent secretion was recovering/resolving.Local edema/swelling was recovering/resolving.Pain was recovering/resolving.Erythema was recovering/resolving.Palpable nodulation/nodular regions was recovering/resolving.Signs of collection was recovering/resolving.

• Brand Name: RESTYLANE
• 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: 10876535
• MDR Text Key: 217438164
• Report Number: 9710154-2020-00092
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2020

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: 04/30/2022
• Device Lot Number: 17248-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/20/2020
• 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
• Treatment: ANTIARRHYTHMIC AGENTS
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 65