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

Lot Number 18727

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious event of swelling at implant site and the non-serious events of pain, erythema and hypersensitivity at implant site were considered expected and possibly related to the treatments.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The potential root cause include treatment procedure or patient's hypersensitivity to the product.Potential contributory factor include underlying autoimmune disorder or juverderm ultra plus.The restylane was used off label.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: routine investigations have been performed and indicate a possible involvement of the product.The reported lot number was valid and verified the reported product.The type of incident is expected following use of the product.Additional investigations including batch record reviews will be performed to exclude a non-conforming product.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 02-sep-2021 by a physician which refers to a (b)(6) female patient.The patient's medical history included autoimmune disorder mentioned to hcp after injection.The patient had no known drug allergies.The patient had not received restylane fillers in the past.However she had previously received treatment with allergan based products.The patient was not taking any concomitant medications.On an unknown date in 2021 (around a month prior to initial injections of filler), the patient had received unspecified covid-19 vaccine.The patient had no illness leading up to the injection, or dental procedures leading in the past 6-12 months.It was unknown if patient had received any other vaccinations in the past 6-12 months.On (b)(6) 2021, the patient received treatment with 1 syringe restylane (lot 18727) to tear troughs, bilaterally and 4 syringes restylane lyft with lidocaine (lot 18163) to temples and malar region bilaterally with unknown injection technique and needle type.The restylane was injected to tear troughs (off label use of device).On (b)(6) 2021, the patient received treatment with 1 syringe restylane (lot 18727) to tear troughs, bilaterally and 2 syringes restylane lyft with lidocaine (lot 18724) to lower face with unknown injection technique and needle type.The patient also received treatment with 5 syringes of juvederm ultra plus (allergan product) to lower face on the same day.On (b)(6) 2021, the patient experienced swelling/edema (implant site oedema), tenderness(implant site pain) and redness(implant site erythema) in the tear trough and malar area.The hcp thought that the patient might be having a possible sensitivity reaction (implant site hypersensitivity).On an unknown date in 2021, the hcp prescribed medrol dosepack[methylprednisolone] for a week and doxycycline [doxycycline] for 2 weeks.The patient showed improvement but the swelling, tenderness and redness came back, so the hcp prescribed a second round of unspecified steroids and antibiotics.The patient again, showed improvement.At some point, the redness and swelling returned and a third round of steroids and antibiotics were prescribed.However on (b)(6) 2021, the patient reported for a third time, localized swelling and redness.On (b)(6) 2021, the hcp injected patient with 40 units of hylenex [vorhyaluronidase alfa] split between the two tear toughs.On (b)(6) 2021, the patient still had some edema (swelling) in the area, so hcp injected 120-130 units of hylenex in the tear trough and malar region.On (b)(6) 2021, the hcp injected another 300 units of hylenex because patient was getting swelling again, this time specifically in the left malar and temple area.The patient showed improvement.However, hcp received a call on (b)(6) 2021 and the patient was getting swelling in the left temple again.Hcp was planning to use as much hylenex as possible when patient would come for follow up on (b)(6) 2021.The swelling was ongoing.Outcome at the time of the report: swelling/edema was not recovered/not resolved/ongoing.Tenderness was recovered/resolved.Redness was recovered/resolved.Possible sensitivity reaction was not recovered/not resolved/ongoing.Restylane was injected to tear troughs was recovered/resolved.

Manufacturer Narrative

Company comment: the serious event of swelling at implant site and the non-serious events of pain, erythema and hypersensitivity at implant site were considered expected and possibly related to the treatments.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The potential root cause include treatment procedure or patient's hypersensitivity to the product.Potential contributory factor include underlying autoimmune disorder or juverderm ultra plus.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 indicate a possible involvement of the products.The reported lot numbers were valid and verified the reported products.The type of incident is expected following use of the product.No potential quality issues have been identified in the manufacturing process of the specified batches.The batches are manufactured and released according to galderma quality management system.The information in this case does not indicate non-conforming products or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: restylane-l-no corrective or preventive actions are deemed necessary based on the performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2021 by a physician which refers to a 56-year-old female patient.The patient's medical history included autoimmune disorder mentioned to hcp after injection.The patient had no known drug allergies.The patient had not received restylane fillers in the past.However she had previously received treatment with allergan based products.The patient was not taking any concomitant medications.On an unknown date in 2021 (around a month prior to initial injections of filler), the patient had received unspecified covid-19 vaccine.The patient had no illness leading up to the injection, or dental procedures leading in the past 6-12 months.It was unknown if patient had received any other vaccinations in the past 6-12 months.On (b)(6) 2021, the patient received treatment with 1 syringe restylane-l (lot 18727) to tear troughs, bilaterally and 4 syringes restylane lyft with lidocaine (lot 18163) to temples and malar region bilaterally with unknown injection technique and needle type.The restylane was injected to tear troughs (off label use of device).On (b)(6) 2021, the patient received treatment with 1 syringe restylane-l (lot 18727) to tear troughs, bilaterally and 2 syringes restylane lyft with lidocaine (lot 18724) to lower face with unknown injection technique and needle type.The patient also received treatment with 5 syringes of juvederm ultra plus (allergan product) to lower face on the same day.On (b)(6) 2021, the patient experienced swelling/edema (implant site oedema), tenderness(implant site pain) and redness(implant site erythema) in the tear trough and malar area.The hcp thought that the patient might be having a possible sensitivity reaction (implant site hypersensitivity).On an unknown date in 2021, the hcp prescribed medrol dosepack[methylprednisolone] for a week and doxycycline [doxycycline] for 2 weeks.The patient showed improvement but the swelling, tenderness and redness came back, so the hcp prescribed a second round of unspecified steroids and antibiotics.The patient again, showed improvement.At some point, the redness and swelling returned and a third round of steroids and antibiotics were prescribed.However on (b)(6) 2021, the patient reported for a third time, localized swelling and redness.On (b)(6) 2021, the hcp injected patient with 40 units of hylenex [vorhyaluronidase alfa] split between the two tear toughs.On (b)(6) 2021, the patient still had some edema (swelling) in the area, so hcp injected 120-130 units of hylenex in the tear trough and malar region.On (b)(6) 2021, the hcp injected another 300 units of hylenex because patient was getting swelling again, this time specifically in the left malar and temple area.The patient showed improvement.However, hcp received a call on (b)(6) 2021 and the patient was getting swelling in the left temple again.Hcp was planning to use as much hylenex as possible when patient would come for follow up on (b)(6) 2021.The swelling was ongoing.Outcome at the time of the report: swelling/edema was not recovered/not resolved/ongoing.Tenderness was recovered/resolved.Redness was recovered/resolved.Possible sensitivity reaction was not recovered/not resolved/ongoing.Restylane was injected to tear troughs was recovered/resolved.Tracking list: v.0 initial version v.1 results from the batch record reviews were received on 24-sep-2021.

• 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: 12516522
• MDR Text Key: 273550307
• Report Number: 9710154-2021-00060
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P040024/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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: 18727
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVEDERM ULTRA PLUS; JUVEDERM ULTRA PLUS
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR