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

Lot Number 18586-1

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Obstruction/Occlusion (2422); Angioedema (4536); Subcutaneous Nodule (4548); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious expected events of vascular occlusion and angioedema, the serious unexpected event of lymphatic obstruction, and the non-serious expected events of pain, hypersensitivity, mass at implant site and discomfort at injection site were considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions.Likely root causes for the events include patient's hypersensitivity to the filler, intravascular injection leading to vascular occlusion and tamponade or compression of local vascular and lymphatic structures by the product and postprocedural swelling.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.Manufacturer narrative: 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 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 06-feb-2021 by an other health professional which refers to a (b)(6) year-old female patient.Additional information was received on 09-feb-2021 from the same reporter.The patient was healthy, had no diseases allergies, and surgery.The patient's wisdom teeth removed (right upper and both lower) in 2020 (12 months ago).The patient was not taking any concomitant medications.The patient had not received any fillers or toxins in the past or vaccines.On (b)(6) 2021, the patient received treatment with 0.5 ml restylane kysse (lot 18586-1) to upper and lower lips (0.25 ml on each side) using 25 g 1.5" tsk cannula with unknown injection technique.There was no complications during the procedure.The area was cleansed with chlorhexidine 2 percent prior.One day later, on (b)(6) 2021, the patient experienced angioedema/swelling(angioedema).It was started to right bottom lip but went down over night.Now this morning the swelling presented to top right lip.Slightly tenderness/pain(implant site pain) with palpation, no pain or bruising.The patient was advised to take 2 benadryl [diphenhydramine hydrochloride] (50mg total) followed by 25mg in 6 hours and 50mg before bed tonight.Hcp considered it as a case of delayed allergic reaction(implant site hypersensitivity).The patient was instructed to text hcp tomorrow morning with progress report or sooner if the swelling worsens.Recommended gentle massage to stimulate lymphatic drainage and intermittent ice application to reduce swelling and discomfort(injection site discomfort).The patient sent a photo which has been uploaded into her file.As per chart notes on (b)(6) 2021, the patient presented with right upper lip swelling (400% larger than appearance post injection) and significant tenderness with palpation (scale 8/10).Swelling confined to right upper and middle lip only.No bruising or discoloration noted.The physician was considering working diagnosis of angioedma caused by impaired lymphatic drainage(lymphatic obstruction) versus vascular occlusion(vascular occlusion) or restriction by tamponade or both.Reasons for diagnosis of angioedema reported as swelling occurred 24-48 hours after the injection and was confined to top and bottom right lip.Swelling went down significantly within 8 hours after ibuprofen [ibuprofen] 400 mg 6 hourly as directed and anti-histamines used.However, the swelling reoccurred the next morning and did not go down even with continued ibuprofen and anti-histamines.No pain at rest and no bruising or discoloration.Reason for diagnosis as vascular occlusion was reported as patient had significant pain with palpation.Swelling was asymmetrical (confined today to the top right lip).Swelling no longer responsive to ibuprofen or diphenhydramine or massage.Right lip was very firm with lumps(implant site mass) x 2.The patient received treatment with 250u of hyaluronidase [hyaluronidase] (3 rounds of injections performed allowing client to rest in between) to top right lip on (b)(6) 2021.Between injections the lip was gently massaged.Warm wet cloths applied.The procedure was performed over the course of 1.5 hours.The right upper lip has softened and the patient reported that it felt less painful with massage.The patient was advised to take aspirin [acetylsalicylic acid] 300 mg bid, as directed to help thin the blood and was useful as an anti-inflammatory.The patient also received keflex [cefalexin] 500 mg 12 hourly from (b)(6) 2021 for 7 days.Outcome at the time of the report: angioedema/swelling was not recovered/not resolved.Vascular occlusion was unknown.Tenderness/pain was recovering/resolving.Delayed allergic reaction was unknown.Discomfort was unknown.Very firm with lumps was unknown.Impaired lymphatic drainage was unknown.

Manufacturer Narrative

Pharmacovigilance comment: the serious expected events of vascular occlusion and angioedema, the serious unexpected event of lymphatic obstruction, and the non-serious expected events of pain, hypersensitivity, mass at implant site and discomfort at injection site were considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions.Likely root causes for the events include patient's hypersensitivity to the filler, intravascular injection leading to vascular occlusion and tamponade or compression of local vascular and lymphatic structures by the product and postprocedural swelling.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.Manufacturer narrative: routine investigations have been performed and indicate a possible involvement of the product.The reported lot number was valid and verified the reported product.An additional investigation involving a batch record review was performed.No potential quality issues were identified in the manufacturing process of the specified batch.The batch was 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 (b)(6) 2021 by a nurse practitioner, which refers to a 20-year-old female patient.Additional information was received on 09-feb-2021 from the same reporter.The patient was healthy, had no diseases allergies, and surgery.The patient's wisdom teeth removed (right upper and both lower) in 2020 (12 months ago).The patient was not taking any concomitant medications.The patient had not received any fillers or toxins in the past or vaccines.On (b)(6) 2021, the patient received treatment with 0.5 ml restylane kysse (lot 18586-1) to upper and lower lips (0.25 ml on each side) using 25 g 1.5" tsk cannula with unknown injection technique.There was no complications during the procedure.The area was cleansed with chlorhexidine 2 percent prior.One day later, on (b)(6) 2021, the patient experienced angioedema/swelling(angioedema).It was started to right bottom lip but went down over night.In the morning of (b)(6) 2021, the swelling presented to top right lip.Slightly tenderness/pain(implant site pain) with palpation, no pain or bruising.The patient was advised to take 2 benadryl [diphenhydramine hydrochloride] (50mg total) followed by 25mg in 6 hours and 50mg before bed.The hcp considered it as a case of delayed allergic reaction(implant site hypersensitivity).The patient was instructed to follow up with hcp if symptoms of swelling worsen.Recommended gentle massage to stimulate lymphatic drainage and intermittent ice application to reduce swelling and discomfort(injection site discomfort).As per chart notes on (b)(6) 2021, the patient presented with right upper lip swelling (400% larger than appearance post injection) and significant tenderness with palpation (scale 8/10).Swelling confined to right upper and middle lip only.No bruising or discoloration noted.The physician was considering working diagnosis of angioedma caused by impaired lymphatic drainage(lymphatic obstruction) versus vascular occlusion(vascular occlusion) or restriction by tamponade or both.Reasons for diagnosis of angioedema was that the swelling occurred 24-48 hours after the injection and was confined to top and bottom right lip.The swelling went down significantly within 8 hours after ibuprofen [ibuprofen] 400 mg 6 hourly as directed and anti-histamines used.However, the swelling reoccurred the next morning and did not go down even with continued ibuprofen and anti-histamines.No pain at rest and no bruising or discoloration.Reason for diagnosis of vascular occlusion was that the patient had significant pain with palpation.Swelling was asymmetrical (confined today to the top right lip).Swelling no longer responsive to ibuprofen or diphenhydramine or massage.Right lip was very firm with lumps(implant site mass) x 2.The patient received treatment with 250u of hyaluronidase [hyaluronidase] (3 rounds of injections performed allowing client to rest in between) to top right lip on (b)(6) 2021.Between injections the lip was gently massaged.Warm wet cloths applied.The procedure was performed over the course of 1.5 hours.The right upper lip has softened and the patient reported that it felt less painful with massage.The patient was advised to take aspirin [acetylsalicylic acid] 300 mg bid, as directed to help thin the blood and was useful as an anti-inflammatory.The patient also received keflex [cefalexin] 500 mg 12 hourly from (b)(6) 2021 for 7 days.Outcome at the time of the report: angioedema/swelling was not recovered/not resolved.Vascular occlusion was unknown.Tenderness/pain was recovering/resolving.Delayed allergic reaction was unknown.Discomfort was unknown.Very firm with lumps was unknown.Impaired lymphatic drainage was unknown.Tracking list: v.0 initial, v.1 batch record review results were received on 18-feb-2021.No potential quality issues were identified in the manufacturing process of the specified batch.

Event Description

Case reference number (b)(4).Is a spontaneous report sent on 06-feb-2021 by a nurse practitioner, which refers to a 20-year-old female patient.Additional information was received on 09-feb-2021 from the same reporter.The patient was healthy, had no diseases allergies, and surgery.The patient's wisdom teeth removed (right upper and both lower) in 2020 (12 months ago).The patient was not taking any concomitant medications.The patient had not received any fillers or toxins in the past or vaccines.On (b)(6) 2021, the patient received treatment with 0.5 ml restylane kysse (lot 18586-1) to upper and lower lips (0.25 ml on each side) using 25 g 1.5" tsk cannula with unknown injection technique.There was no complications during the procedure.The area was cleansed with chlorhexidine 2 percent prior.One day later, on (b)(6) 2021, the patient experienced angioedema/swelling(angioedema).It was started to right bottom lip but went down over night.In the morning of (b)(6) 2021, the swelling presented to top right lip.Slightly tenderness/pain(implant site pain) with palpation, no pain or bruising.The patient was advised to take 2 benadryl [diphenhydramine hydrochloride] (50mg total) followed by 25mg in 6 hours and 50mg before bed.The hcp considered it as a case of delayed allergic reaction(implant site hypersensitivity).The patient was instructed to follow up with hcp if symptoms of swelling worsen.Recommended gentle massage to stimulate lymphatic drainage and intermittent ice application to reduce swelling and discomfort(injection site discomfort).As per chart notes on (b)(6) 2021, the patient presented with right upper lip swelling (400% larger than appearance post injection) and significant tenderness with palpation (scale 8/10).Swelling confined to right upper and middle lip only.No bruising or discoloration noted.The physician was considering working diagnosis of angioedma caused by impaired lymphatic drainage(lymphatic obstruction) versus vascular occlusion(vascular occlusion) or restriction by tamponade or both.Reasons for diagnosis of angioedema was that the swelling occurred 24-48 hours after the injection and was confined to top and bottom right lip.The swelling went down significantly within 8 hours after ibuprofen [ibuprofen] 400 mg 6 hourly as directed and anti-histamines used.However, the swelling reoccurred the next morning and did not go down even with continued ibuprofen and anti-histamines.No pain at rest and no bruising or discoloration.Reason for diagnosis of vascular occlusion was that the patient had significant pain with palpation.Swelling was asymmetrical (confined today to the top right lip).Swelling no longer responsive to ibuprofen or diphenhydramine or massage.Right lip was very firm with lumps(implant site mass) x 2.The patient received treatment with 250u of hyaluronidase [hyaluronidase] (3 rounds of injections performed allowing client to rest in between) to top right lip on (b)(6) 2021.Between injections the lip was gently massaged.Warm wet cloths applied.The procedure was performed over the course of 1.5 hours.The right upper lip has softened and the patient reported that it felt less painful with massage.The patient was advised to take aspirin [acetylsalicylic acid] 300 mg bid, as directed to help thin the blood and was useful as an anti-inflammatory.The patient also received keflex [cefalexin] 500 mg 12 hourly from (b)(6)2021 for 7 days.As per the follow up information received on 12-mar-2021, the hcp reported that the issue had completely resolved.Outcome at the time of the report: angioedema/swelling was recovered/resolved.Vascular occlusion was recovered/resolved.Impaired lymphatic drainage was recovered/resolved.Tenderness/pain was recovered/resolved.Delayed allergic reaction was recovered/resolved.Discomfort was recovered/resolved.Very firm with lumps was recovered/resolved.Tracking list: v.0 initial, v.1 batch record review results were received on 18-feb-2021.No potential quality issues were identified in the manufacturing process of the specified batch.V.2 fu received on 12-mar-2021 from the same reporter: outcome of the events updated as resolved.

Manufacturer Narrative

Pharmacovigilance comment: the serious expected events of vascular occlusion and angioedema, the serious unexpected event of lymphatic obstruction, and the non-serious expected events of pain, hypersensitivity, mass at implant site and discomfort at injection site were considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions.Likely root causes for the events include patient's hypersensitivity to the filler, intravascular injection leading to vascular occlusion and tamponade or compression of local vascular and lymphatic structures by the product and postprocedural swelling.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.Manufacturer narrative: routine investigations have been performed and indicate a possible involvement of the product.The reported lot number was valid and verified the reported product.An additional investigation involving a batch record review was performed.No potential quality issues were identified in the manufacturing process of the specified batch.The batch was 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.

• Brand Name: RESTYLANE KYSSE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 11374990
• MDR Text Key: 242713210
• Report Number: 9710154-2021-00012
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P140029/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Lot Number: 18586-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR