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

Lot Number 16149-1

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

Patient Problems Abscess (1690); Cellulitis (1768); Edema (1820); Extravasation (1842); Unspecified Infection (1930); Pain (1994); Skin Discoloration (2074); Swelling (2091); Discomfort (2330); Skin Inflammation (2443); Pallor (2468); Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Capa: 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.Manufacturing narrative: the reported lot number was valid.Pharmacovigilance comment: the serious expected events of oedema, inflammation, abscess, vascular compression, possible infection at the implant site and serious unexpected event of cellulitis and the non-serious expected events of pain, pallor, mass, exfoliation and nodule at implant site, injection site discomfort and unexpected event of extravasation at implant site and swelling face were considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent harm; and need for hospitalization prevented by lack of insurance.Potential etiologies include prolonged inflammation and infection of the lip.Potential contributory factors include injection technique.The case met the seriousness criteria for expedited reporting to the regulatory authorities.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 07-apr-2020 by a physician )hich refers to a (b)(6) old female patient.Additional information was received on 07-apr-2020.No information about medical history, concomitant medication, history of allergies has been provided.The patient had previously received treatment with unspecified filler.On (b)(6) 2020, the patient received treatment with 1 ml restylane kysse (lot 16149-1) to the upper and lower lip (0.25 ml per treated area) using an unspecified cannula with retroinjection technique.During the procedure the dentist felt something strange, pressure of some material, but he continued and the procedure ended well as clinical dentist evaluation.The physician attended a patient that was injected with restylane, for lip filling, by another health professional, a dentist.The patient sought her for resolution of the clinical condition.Same day, on (b)(6) 2020, the patient had experienced pain(implant site pain) on the upper and lower lips extending through the labial commissure and remained after the end of the procedure.2 days later, on (b)(6) 2020, the patient experienced edema(implant site oedema), discomfort (injection site discomfort).After few days, on an unknown date in (b)(6) 2020, the patient was uncomfortable and she experienced small bumps/palpating rigid areas(implant site mass) on her lip.On (b)(6) 2020, the dentist evaluated the patient and noticed palpating rigid areas but did not understand what was going on so, she decided to apply hyaluronidase [hyaluronidase] 1 bottle of 2000rt spread and massaging, after hyaluronidase application, the patient became very swollen.On 20-mar-2020, the patient reported improvement.In the following days the patient evolved with improvement, but in the afternoon, patient sent a photo that looked like a desquamative lesions (implant site exfoliation) and in the following days she seemed to be better.On (b)(6) 2020, the patient experienced edema that returned on the right side and reported discomfort.The reporter had access to some photos and verified that the region was pale with the mucosa (implant site pallor) as if there were some pressed vessel/possible clinical condition of vascular obstruction (vascular occlusion), but with no sign of tissue necrosis.The physician believed that could have previously occurred a clinical condition of vascular obstruction but that currently there was no signs of ischemia.The reporter assessed the causality as to generate a possible infectious process(implant site infection), response of the host, breaking biofilm.As medication treatment, the patient was using oral antibiotics and two cycles of oral corticosteroid [corticosteroid nos] were prescribed, but without positive response.Additionally, the reporter informed that an ultrasound examination was performed, there were some spots in the region with inflammatory (implant site inflammation) fluid (implant site extravasation), which needed to be drained.There was a lot of fluid in addition to hyaluronic acid at the site.On (b)(6) 2020, the patient was injected with decadron [dexamethasone] 4mg, once a day, for 3 weeks.On (b)(6) 2020, the patient started an antibiotic regimen ciprofloxacin [ciprofloxacin] 500 mg associated with clarithromycin [clarithromycin] 500 mg, initial for 14 days and could be extend for 21 days.The patient was not hospitalized due the adverse events.On (b)(6) 2020, the patient performed a computed tomography to evaluate any infection from the bone point of view, of the bone structures that some lesions, implants and grafts were detected.The galderma's dentist employee informed that the dentist who applied the restylane informed that the patient had sought for a dermatologist.On (b)(6) 2020, the patient performed a doppler ultrasound with color.Impression: correspondingly the palpable nodular areas(implant site nodule) stand out, well-defined, liquid-thick collections on the upper and lower lips.The study of the upper and lower lips showed the presence of oval, elongated, well-defined images with heterogeneous echogenicity, suggesting thick liquid content, which may correspond to thick liquid collections.The largest collections measure about 1.5 into 0.4 cm and 1.3 into 0.5 cm.Peripheral vascularization stood out when studying these collections.In contiguity the collection in the upper right corner, a string of probable inflammatory nature stood out, that extended by the oral mucosa, inside the right cheek superficially, measuring about 4.0 cm in length and 0.3 cm thick.Right parotid with usual ultrasound aspect.Rare and sparse deposits of hyaluronic acid of habitual aspect in bilateral nasolabial sulcus.There was no evidence of other cosmetic fillers in the study of the face.Vascular structures of usual appearance, without evidence of filling flaws.The patient's photos were attached on the supporting documents.Tissue of probable inflammatory nature extending from the collection in the upper right corner of the lip, through the mucosa of the inner part of the mouth, on the right cheek in the form of a cord, corresponding to the clinical palpation.The dentist informed that the patient was instinctively spending all night touching her face and running the tongue over the inner string of her cheek and this was repeated for several nights and also during the day.The patient face remained swollen (swelling face).The patient would like to return to work but she had no physical and psychological conditions to go, because her clinical condition embarrassed and disturbed her self-esteem.The reporter assessed the adverse event as moderate.As per follow up information received on 17-apr-2020, the physician believed that the patient was on the 40th day of antibiotics.The dentist performed draining the material along with hyalozyme and it was horrible and the physician clarified that the patient was better but with a lot of edema and the dentist decided to change the treatment for amoxicillin.The physician asked for another physician evaluate the situation who thought prudent to hospitalize the patient, but she had no health insurance, so it was not performed.The physician also informed that the dentist who injected the product insisted on informing that there was no infection.No further information was provided.Outcome at the time of the report: pain was recovering/resolving.Edema was not recovered/not resolved.Pale with the mucosa was recovering/resolving.Some pressed vessel/possible clinical condition of vascular obstruction was recovering/resolving.Inflammatory was recovering/resolving.Fluid was recovering/resolving.Possible infectious process was recovering/resolving.Palpable nodular areas was recovering/resolving.Discomfort was recovering/resolving.Face remained swollen was not recovered/not resolved.Small bumps/palpating rigid areas was recovering/resolving.Desquamative lesions was recovering/resolving.Tracking list: v.0 initial received on 07-apr-2020 from physician v.1 fu received on 09-apr-2020 from physician, 10-apr-2020 and 15-apr-2020 from dentist: events (discomfort, nodule, infection at implant, swelling face) were added.Event coding changed from vascular compression to vascular occlusion.Patient demographics, past filler treatment, suspect device implant date, volume, needle type, injection technique, lot number, expiry date, event outcome, severity and corrective treatment details were updated.V.2 fu received on 20-mar-2020 and 06-apr-2020 from dentist: events (small bumps and desquamative lesions) were added.Laboratory test result updated.Due to data base restrictions, we are unable enter earliest day zero in the latest received date field of general tab.V.3 fu received on 17-apr-2020 from physician: outcome of event was updated.

Manufacturer Narrative

Capa: 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.Manufacturing narrative: the reported lot number was valid.Pharmacovigilance comment: the serious expected events of oedema, inflammation, abscess, vascular compression, possible infection at the implant site and serious unexpected event of cellulitis and the non-serious expected events of pain, pallor, mass, exfoliation and nodule at implant site, injection site discomfort and unexpected event of extravasation at implant site and swelling face were considered possibly related to the treatment.Serious criteria incude the need for multiple medical interventions to prevent permanent harm; and need for hospittalization prevented by lack of insurance.Potential etiologies include prolonged inflammation and infection of the lip.Potential contributory factors include injection technique.The case met the seriousness criteria for expedited reporting to the regulatory authorities.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 07-apr-2020 by a physician which refers to a 57-year-old female patient.Additional information was received on 07-apr-2020.No information about medical history, concomitant medication, history of allergies has been provided.The patient had previously received treatment with unspecified filler.On (b)(4) 2020, the patient received treatment with 1 ml restylane kysse (lot 16149-1) to the upper and lower lip (0.25 ml per treated area) using an unspecified cannula with retroinjection technique.During the procedure the dentist felt something strange, pressure of some material, but he continued and the procedure ended well as clinical dentist evaluation.The physician attended a patient that was injected with restylane, for lip filling, by another health professional, a dentist.The patient sought her for resolution of the clinical condition.Same day, on (b)(4) 2020, the patient had experienced pain(implant site pain) on the upper and lower lips extending through the labial commissure and remained after the end of the procedure.2 days later, on (b)(6) 2020, the patient experienced edema(implant site oedema), discomfort(injection site discomfort).After few days, on an unknown date in (b)(4) 2020, the patient was uncomfortable and she experienced small bumps/palpating rigid areas(implant site mass) on her lip.On (b)(6) 2020, the dentist evaluated the patient and noticed palpating rigid areas but did not understand what was going on so, she decided to apply hyaluronidase [hyaluronidase] 1 bottle of 2000rt spread and massaging, after hyaluronidase application, the patient became very swollen.On (b)(6) 2020, the patient reported improvement.In the following days the patient evolved with improvement, but in the afternoon, patient sent a photo that looked like a desquamative lesions(implant site exfoliation) and in the following days she seemed to be better.On (b)(6) 2020, the patient experienced edema that returned on the right side and reported discomfort.The reporter had access to some photos and verified that the region was pale with the mucosa(implant site pallor) as if there were some pressed vessel/possible clinical condition of vascular obstruction (vascular occlusion), but with no sign of tissue necrosis.The physician believed that could have previously occurred a clinical condition of vascular obstruction but that currently there was no signs of ischemia.The reporter assessed the causality as to generate a possible infectious process(implant site infection), response of the host, breaking biofilm.As medication treatment, the patient was using oral antibiotics and two cycles of oral corticosteroid [corticosteroid nos] were prescribed, but without positive response.Additionally, the reporter informed that an ultrasound examination was performed, there were some spots in the region with inflammatory(implant site inflammation) fluid (implant site extravasation), which needed to be drained.There was a lot of fluid in addition to hyaluronic acid at the site.On (b)(6) 2020, the patient was injected with decadron [dexamethasone] 4mg, once a day, for 3 weeks.On (b)(6) 2020, the patient started an antibiotic regimen ciprofloxacin [ciprofloxacin] 500 mg associated with clarithromycin [clarithromycin] 500 mg, initial for 14 days and could be extend for 21 days.The patient was not hospitalized due the adverse events.On (b)(6) 2020, the patient performed a computed tomography to evaluate any infection from the bone point of view, of the bone structures that some lesions, implants and grafts were detected.The galderma's dentist employee informed that the dentist who applied the restylane informed that the patient had sought for a dermatologist.On (b)(6) 2020, the patient performed a doppler ultrasound with color.Impression: correspondingly the palpable nodular areas(implant site nodule) stand out, well-defined, liquid-thick collections on the upper and lower lips.The study of the upper and lower lips showed the presence of oval, elongated, well-defined images with heterogeneous echogenicity, suggesting thick liquid content, which may correspond to thick liquid collections.The largest collections measure about 1.5 into 0.4 cm and 1.3 into 0.5 cm.Peripheral vascularization stood out when studying these collections.In contiguity the collection in the upper right corner, a string of probable inflammatory nature stood out, that extended by the oral mucosa, inside the right cheek superficially, measuring about 4.0 cm in length and 0.3 cm thick.Right parotid with usual ultrasound aspect.Rare and sparse deposits of hyaluronic acid of habitual aspect in bilateral nasolabial sulcus.There was no evidence of other cosmetic fillers in the study of the face.Vascular structures of usual appearance, without evidence of filling flaws.The patient's photos were attached on the supporting documents.Tissue of probable inflammatory nature extending from the collection in the upper right corner of the lip, through the mucosa of the inner part of the mouth, on the right cheek in the form of a cord, corresponding to the clinical palpation.The dentist informed that the patient was instinctively spending all night touching her face and running the tongue over the inner string of her cheek and this was repeated for several nights and also during the day.The patient face remained swollen/intense edema on the face (swelling face).The patient would like to return to work but she had no physical and psychological conditions to go, because her clinical condition embarrassed and disturbed her self-esteem.The reporter assessed the adverse event as moderate.As per follow up information received on 17-apr-2020, the physician believed that the patient was on the 40th day of antibiotics.The dentist performed draining the material along with hyalozyme and it was horrible and the physician clarified that the patient was better but with a lot of edema and the dentist decided to change the treatment for amoxicillin.The physician asked for another physician evaluate the situation who thought prudent to hospitalize the patient, but she had no health insurance, so it was not performed.The physician also informed that the dentist who injected the product insisted on informing that there was no infection.As per follow-up information received on 17-apr-2020, the reporter informed that the patient was referred to her from another dermatologist.The reporter informed that the ultrasound aspect was with several abscesses (implant site abscess) on the lip, with the formation of plastron extending to the area outside the lip.The physician was very concerned, as the patient had intense edema on the face and the fact that she had been subjected to so many sessions of hyaluronidase could have spread the infection and evolved to possible face cellulitis(cellulitis).The patient had no health plan to be hospitalized for intravenous antibiotic.On an unknown date, the reporter attended the patient, it was reported that patient was much better and well clinically.The patient was advised the patient to undergo tests to assess the infectious inflammatory profile.No further information was provided.Outcome at the time of the report: pain was recovering/resolving.Edema was not recovered/not resolved.Pale with the mucosa was recovering/resolving.Some pressed vessel/possible clinical condition of vascular obstruction was recovering/resolving.Inflammatory was recovering/resolving.Fluid was recovering/resolving.Possible infectious process was recovering/resolving.Palpable nodular areas was recovering/resolving.Discomfort was recovering/resolving.Face remained swollen was not recovered/not resolved.Small bumps/palpating rigid areas was recovering/resolving.Desquamative lesions was recovering/resolving.Abscesses was recovering/resolving.Possible face cellulitis was recovering/resolving.Tracking list: v.0 initial v.1 fu received on 09-apr-2020 from physician, 10-apr-2020 and 15-apr-2020 from dentist: events (discomfort, nodule, infection at implant, swelling face) were added.Event coding changed from vascular compression to vascular occlusion.Patient demographics, past filler treatment, suspect device implant date, volume, needle type, injection technique, lot number, expiry date, event outcome, severity and corrective treatment details were updated.V.2 fu received on 20-mar-2020 and 06-apr-2020 from dentist: events (small bumps and desquamative lesions) were added.Laboratory test result updated.Due to data base restrictions, we are unable enter earliest day zero in the latest received date field of general tab.V.3 fu received on 17-apr-2020 from physician: outcome of event was updated.V.4 fu received on 17-apr-2020 from a second reporter physician: events (abscess and cellulitis) added.Event verbatim of swelling face, outcome of implant site oedema and ultrasound test result were updated.

• Brand Name: RESTYLANE KYSSE
• 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: 10153651
• MDR Text Key: 201191972
• Report Number: 9710154-2020-00049
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• 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
• Report Date: 06/23/2020

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: No Information
• Device Expiration Date: 04/30/2020
• Device Lot Number: 16149-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 67