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

Lot Number 18164-1

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

Patient Problems Abscess (1690); Purulent Discharge (1812); Erythema (1840); Granuloma (1876); Pain (1994)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

Pharamcovigilance comments: the serious expected event of abscess at implant site and the non-serious expected events of pain, erythema at implant site, granuloma skin and purulent discharge were considered possibly related to the treatment.Serious criteria include the need for multiple medical and surgical interventions.Potential root cause for abscess at implant site include injection procedure associated with inadequate aseptic technique leading to its manifestations and microbial contamination from respiratory or dental sources.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacturing narrative: 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.A batch record review of the reported lot number has been requested.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2021 by an other health professional which refers to a (b)(6) year-old female patient.Additional information was received on (b)(6) 2021 by the same reporter.The patient's medical history included anxiety.Concomitant treatments included ativan [ativan] for anxiety when necessary.No information about history of allergies or past filler treatment has been reported.On (b)(6) 2020, the patient received treatment with 0.3 ml restylane defyne (lot 18164-1) to nose bridge to correct atrophic scar on lateral left bridge/tip using an unspecified cannula with unknown injection technique.On (b)(6) 2020, the patient received touch up treatment with 0.3 ml restylane defyne (lot 18164-1) to nose bridge using an unspecified cannula with unknown injection technique.99 days later, on (b)(6) 2021, the patient contacted hcp with concerns of pain(implant site pain) and erythema(implant site erythema) overlying the treatment area.The hcp prescribed clindamycin [clindamycin] 300mg per oral, three times a day and organized an appointment to see patient on (b)(6) 2021.When patient was seen, hcp noticed that there was a localized abscess/fluctuant mass(implant site abscess) overlying the treatment area approximately 1cm x 1cm.The hcp performed an incision and drainage.The wound was too small to pack and hcp felt like had manually drained all of the pus(purulent discharge).2 days later, on (b)(6) 2021, the patient went to the emergency room as it had appeared to have reaccumulated.They performed another incision and drainage and started her on keflex [cefalexin] and septra [trimethoprim, sulfamethoxazole].Clindamycin was discontinued.The patient went back to the er the next day and at this point patient had undergone another incision and drainage and was referred to plastic physician.Plastic physician saw the patient and patient indicated some filler was drained.They planned to continue oral antibiotic for a week to see if there was an improvement.If there was no improvement, the patient may need surgery to scrape out the granuloma(granuloma skin).Outcome at the time of the report: localized abscess/fluctuant mass was not recovered/not resolved.Drained all of the pus was unknown.Pain was unknown.Erythema was unknown.Granuloma was unknown.

Manufacturer Narrative

Pharamcovigilance comments: the serious expected event of abscess at implant site and the non-serious expected events of pain, erythema at implant site, granuloma skin and purulent discharge were considered possibly related to the treatment.Serious criteria include the need for multiple medical and surgical interventions.Potential root cause for abscess at implant site include injection procedure associated with inadequate aseptic technique leading to its manifestations and microbial contamination from respiratory or dental sources.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacturing narrative: 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.A repeat batch record review of the reported lot number was performed.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 11-jan-2021 by an other health professional which refers to a 42-year-old female patient.Additional information was received on 13-jan-2021 by the same reporter.The patient's medical history included anxiety.Concomitant treatments included ativan [ativan] for anxiety when necessary.No information about history of allergies or past filler treatment has been reported.On (b)(6) 2020, the patient received treatment with 0.3 ml restylane defyne (lot 18164-1) to nose bridge to correct atrophic scar on lateral left bridge/tip using an unspecified cannula with unknown injection technique.On (b)(6) 2020, the patient received touch up treatment with 0.3 ml restylane defyne (lot 18164-1) to nose bridge using an unspecified cannula with unknown injection technique.99 days later, on (b)(6) 2021, the patient contacted hcp with concerns of pain(implant site pain) and erythema(implant site erythema) overlying the treatment area.The hcp prescribed clindamycin [clindamycin] 300mg per oral, three times a day and organized an appointment to see patient on (b)(6) 2021.When patient was seen, hcp noticed that there was a localized abscess/fluctuant mass(implant site abscess) overlying the treatment area approximately 1cm x 1cm.The hcp performed an incision and drainage.The wound was too small to pack and hcp felt like had manually drained all of the pus(purulent discharge).2 days later, on (b)(6) 2021, the patient went to the emergency room as it had appeared to have reaccumulated.They performed another incision and drainage and started her on keflex [cefalexin] and septra [trimethoprim, sulfamethoxazole].Clindamycin was discontinued.The patient went back to the er the next day and at this point patient had undergone another incision and drainage and was referred to plastic physician.Plastic physician saw the patient and patient indicated some filler was drained.They planned to continue oral antibiotic for a week to see if there was an improvement.If there was no improvement, the patient may need surgery to scrape out the granuloma(granuloma skin).Outcome at the time of the report: localized abscess/fluctuant mass was not recovered/not resolved.Drained all of the pus was unknown.Pain was unknown.Erythema was unknown.Granuloma was unknown.Tracking list: v.0 initial included data from (b)(6) 2021 and (b)(6) 2021 v.1 opened to add brr results.No new information received from the reporter included data from (b)(6) 2021.

• Brand Name: RESTYLANE DEFYNE
• 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: 11230344
• MDR Text Key: 232869140
• Report Number: 9710154-2021-00003
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P140029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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 Lot Number: 18164-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATIVAN (LORAZEPAM) AS NEEDED FOR ANXIETY; ATIVAN (LORAZEPAM) AS NEEDED FOR ANXIETY
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR