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

Lot Number 18885

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

Patient Problems Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Skin Infection (4544); Subcutaneous Nodule (4548); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

The serious expected event of infection at implant site was considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The potential root cause include injection procedure associated with inadequate aseptic technique.The restylane-l was used off label.The case meets the criteria for expedited reporting to the regulatory authorities.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 12-aug-2021 by an other health professional concerning a (b)(6) old female patient.Additional information was received on (b)(6) 2021 from same reporter.The patient's medical history included percocet allergy.The patient was not taking any concomitant medications.The patient had previously received treatment with restylane-l on (b)(6) 2011, (b)(6) 2013 and (b)(6) 2015 to bilateral lower eyelids.On an unknown date in (b)(6) 2020, the patient had received unspecified vaccine.On (b)(6) 2021, the patient had received first dose of moderna covid-19 vaccine.On (b)(6) 2021, the patient had received second dose of moderna covid-19 vaccine.The patient had no illness in the month prior to the treatment.On (b)(6) 2021, the patient received treatment with 1 ml restylane-l (lot 18885), 0.5 ml each to lower eyelids using needle on periosterm with unknown injection technique.The restylane-l was injected to bilateral lower eyelids (off label use of device).On (b)(6) 2021, the patient experienced severe infection (implant site infection) at right lower eyelid.On (b)(6) 2021, the patient underwent routine dental cleaning.Since (b)(6) 2021, the patient had multiple visits and received corrective treatment with 5 to 6 vials hylenex [vorhyaluronidase alfa], biaxin [clarithromycin] 500 mg, minocycline [minocycline] 100 mg bid, celebrex [celebrex] 200 mg bid and colchicine [colchicine] 0.6 mg qd/bd.The event was improved and ongoing.Outcome at the time of the report: infection was recovering/resolving.

Manufacturer Narrative

Company comment: the serious events of infection and nodule at implant site and the non-serious events of swelling, pain and erythema at implant site, and purulent discharge were considered expected and possibly related to the treatment.Serious criteria include the need for surgical and multiple medical interventions to prevent permanent damage.The potential root cause include injection procedure associated with inadequate aseptic technique and the patient past medical history.The restylane-l was used off label.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.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.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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 12-aug-2021 by an other health professional concerning a 45-year-old female patient.Additional information was received on 18-aug-2021 from the same reporter.The patient's medical history included percocet allergy and throat swells.The patient was not taking any concomitant medications.The patient had previously received treatments with restylane-l (lot 10458), 1/2 vial to each lower eyelid using supplied needle on (b)(6) 2011, restylane-l(lot 11588) 1/2 vial to each lower lid, restylane lyft (lot 17691) 1/2 vial to each side of cheekbone and mid face using supplied needle on (b)(6) 2013, restylane-l 1/4 vial to each lower eyelid on (b)(6) 2015, restylane silk (lot 13851) 1/2 vial to each lower eyelid on (b)(6) 2016, voluma (lot vb20a50277) 1/4 vial to each lower eyelid on (b)(6) 2016, restylane defyne (lot 14877), 1/2 vial to each side of mid face, cheek, nasolabial fold on (b)(6) 2017, voluma (lot vb20a70471) 11/2 vial to each side of mid face, cheek, nasolabial fold on (b)(6) 2017 and restylane lyft (lot 16114) 1/2 vial to each lower lid.On (b)(6) 2021, the patient had received first dose of moderna covid-19 vaccine.On (b)(6) 2021, the patient had received second dose of moderna covid-19 vaccine.The patient had no illness in the month prior to the treatment.On (b)(6) 2021, the patient received treatment with 1 ml restylane-l (lot 18885), 0.5 ml each to lower eyelids using supplied needle with unknown injection technique.The restylane-l was injected to bilateral lower eyelids (off label use of device).On (b)(6) 2021, the patient visited hcp office, the right eye was the size of a half lemon, swollen (implant site swelling), red (implant site erythema) and pain (implant site pain) in right lower eyelid and cheek.The hcp stated that it was obviously a biofilm/infection (implant site infection).The patient underwent i&d with pus (purulent discharge) coming out.On (b)(6) 2021, the patient underwent routine dental cleaning.Since (b)(6) 2021, the patient had multiple visits and received corrective treatment with 5 to 6 vials hylenex [vorhyaluronidase alfa], biaxin [clarithromycin] 500 mg, minocycline [minocycline] 100 mg bid, celebrex [celebrex] 200 mg bid and colchicine [colchicine] 0.6 mg qd/bd.The patient was injected with hylenex 19 times by the hcp and she still had nodules (implant site nodule).According to the hcp, after each injection of hylenex, the symptoms resolved but then came back.The patient had been on months of biaxin, doxycycline [doxycycline] and two doses of colchicine.On (b)(6) 2021, the hcp treated the patient with two antibiotics, 4.5 ml of hylenex, 1 ml of lidocaine [lidocaine], 2/3 ml of kenalog 10 [triamcinolone acetonide] and 1 ml of 5-fu [fluorouracil].It was flat after injecting but hcp said it would come back.Outcome at the time of the report: infection/ biofilm was recovered/resolved.Red was not recovered/not resolved/ongoing.Pain was not recovered/not resolved/ongoing.Swollen was not recovered/not resolved/ongoing.Nodule was not recovered/not resolved/ongoing.Pus was unknown.Restylane-l was injected to bilateral lower eyelids was recovered/resolved.Tracking list: v.0 initial; v.1 fu received on 11-nov-2021 and 22-nov-2021 from physician.Events (red, pain, swollen, nodule and pus) added.Medical history, past filler treatment, suspect device needle type and corrective treatment details updated.

• Brand Name: RESTYLANE-L
• 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: 12374731
• MDR Text Key: 268671048
• Report Number: 1000118068-2021-00025
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

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: 08/31/2023
• Device Lot Number: 18885
• 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: 12/09/2021
• Distributor Facility Aware Date: 11/11/2021
• Event Location: Other
• Date Report to Manufacturer: 11/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female