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| Lot Number 17797-1 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Granuloma (1876); Deformity/ Disfigurement (2360); Subcutaneous Nodule (4548); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 07/28/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Pharmacovigilance comment: the serious events of oedema at implant site and granuloma skin and the non-serious event of induration at implant site were considered expected and possibly related to the treatments.Serious criteria includes multiple medical interventions to prevent permanent damage including hyaluronidase, antibiotics, antihistamines and repeated courses of steroids.The non-serious event of device dislocation was considered expected and possibly related to the treatment with restylane volyme and restylane defyne, and unexpected and unrelated to restylane refyne since restylane refyne was only administered to the lower face and could not have impacted the affected areas.The reporter only considered a causal relationship to the restylane defyne treatments.The root cause for the events include product characteristics with known risks for delayed onset inflammatory reactions and low grade biofilm infections.An underlying dental infection might also have precipitated the inflammatory reaction.There was no biopsy, or histopathological confirmation of granuloma reported.The case meets the seriousness criteria for expedited reporting to the regulatory authorities.Engineering evaluation (capa comment): 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.Manufacturer narrative: the reported lot numbers were valid.
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Event Description
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Case reference number: (b)(4) is a spontaneous report sent on 30-jul-2020 by a physician which refers to a (b)(6)-year-old female patient.The patient had volume loss in cheek area, mentolabial folds and chin wrinkles.The patient's medical history included allergy to pollen, unspecified hairs, unspecified nuts and slightly low blood pressure.The patient had previously received treatment with unspecified ha filler to nasolabial folds and both lower eyelids around 3 to 5 years ago from the time of the report.According to the treatment report of the physician, the patient consulted the physician due to volume loss in her face for the first time on (b)(6) 2020.After analysis, photo documentation, consulting and patient education, the treatment with hyaluronic acid was scheduled.On (b)(6) 2020, the patient received treatment with 2 ml restylane volyme (lot#: s2192900005), to preauricular area (0.5 ml per side) and mid face (0.5 ml per side) due to volume loss in that area.The injections were performed with a blunt cannula in fan-shape pattern.Same day, on (b)(6) 2020, the patient received treatment with 2 ml restylane defyne (s2190430008), 0.7 ml to each temporal areas and 0.3 ml to each cheek.The injections were performed with a pointed needle under use of bolus technique.The treatment was performed without problems, or side effects.On (b)(6) 2020, during a control visit with photo documentation, the patient was very satisfied with the results.On (b)(6) 2020, the patient again received treatment with restylane defyne (lot#: 17667-1), 0.2 ml to chin dimples with a blunt cannula in linear technique with subcision and 0.4 ml to each pre-jowl sulcus using supra periosteal bolus technique and a pointed needle.The patient also received treatment with 1 ml restylane refyne (lot#: 17797-1) to corners of the mouth (0.4 ml per side) in fan-shape pattern and to the chin wrinkles each 0.1 ml of the product were administered with linear technique.The injections were performed with a pointed needle.On (b)(6) 2020, the patient received treatment with 1 ml restylane fynesse (lot s2192240012) to upper lip with a pointed needle under use of blanching technique.On (b)(6) 2020, at the control visit with again photo documentation, the patient again was very satisfied with the results.Because there were no conspicuities during course, the treatment was completed.95 days after restylane volyme, restylane defyne and 54 days after restylane refyne, restylane defyne injection, on (b)(6) 2020, the patient experienced severe edematous swelling(implant site oedema) and palpable granuloma formation(granuloma skin) on lower eyelids, cheeks and pre-jowl sulci.Also experienced induration (implant site induration) especially in the areas that were injected with restylane volyme.The induration predominantly occurred on the right cheek and less pronounced on the left cheek, not at the injection site but above, on the orbital rim, above the tear trough and lower.Two days later in the chin areas that were injected with restylane defyne.The reporter especially worried about the migration of volyme(device dislocation) into the tear trough, which he did not inject into at all.On an unknown date in 2020, ultrasound examination revealed a clearly visible fluid depot, indurated and lying in the tissue like a sausage, although the product had been injected in a fan-shaped pattern.At the chin, only on the left side an induration and granuloma formation was observed.After the initial treatment of the cheeks, the product migrated to the lower eyelids (confirmed by ultrasound).Also a persistent intermittent delayed swelling pids occurred.On (b)(6) 2020, a corrective treatment was performed with 60 iu of hylase [hyaluronidase] in tear trough and with 50-50 of a unspecified corticoid [corticosteroid nos].Also unspecified antihistamine and antibiotics were given.A decent improvement of the severe initial swelling was noticed.On (b)(6) 2020, the next hylase treatment was performed due to increasing granuloma formation: 60 iu to the right lower eyelid, 20 iu to the left lower eyelid, 20 iu to the right sulcus, 40 iu to the left pre jowl sulcus.After the treatment an improvement was noticed.Further corrective treatment was given with antihistamines and antibiotics both not specified.Due to increasing swelling during course, the patient was also treated with a non specified corticoid from early (b)(6) 2020 onwards starting with 50 mg of the product.The success of corrective treatment was only moderate, the eye area was always swollen and edema formation occurred.Corticoid therapy showed an improvement of the findings, but recurrent swellings of the lower eyelids on both sides remained.Granuloma formation in the eye area aggravated during course and also occurred now on her mentolabial fold.On (b)(6) 2020, more hyaluronidase was applied as 10 units to each of two injection points at the left tear trough, 10 units to each of two injection points per side at the mentolabial folds, and 20 units to the left pre-jowl sulcus.On (b)(6) 2020, next hyaluronidase treatment was performed, this time due to isolated granuloma on chin or sulcus, 30 units to left and 20 units to right pre-jowl sulcus, and further 30 units in total to two injection points at the left mentolabial fold.On around (b)(6) 2020, the patient presented to another physician in a dermatologic clinic for a 2nd medical opinion as recommended by her attending physician.Since then she also took allopurinol [allopurinol].On (b)(6) 2020, the left mentolabial fold and pre-jowl sulcus were treated with 30 units of hyaluronidase to each of 3 injection points.On (b)(6) 2020, 90 iu hyaluronidase was injected to the left sulcus due to new granuloma formation.After 2-3 days there was a new induration and swelling, now much smaller, but still present.The patient also reacted to hylase with a swelling of the face and not only at the injection site, as the physician had observed otherwise.At the time of the report, the corrective treatment was still ongoing and the patient had not recovered.Severity of the adverse events was classified as moderate.The reporter assessed causality between the adverse events and restylane volyme and restylane defyne as possible.A biopsy was planned for mid (b)(6) 2020.On (b)(6) 2020, due to inconsistencies of the previously provided information, the reporter answered to requests for clarification by sending in the treatment documentation.He stated that on the reporting form, he erroneously had only mentioned the products that had provoked the adverse reactions in his opinion.As per follow up information received on 15-nov-2020, patient herself contacted the medical advisor by e-mail including a picture of the patient, the treatment report of the attending physician (reporter) and the treatment documentation (the latter had already been submitted on 30-sep-2020 by the reporting physician).On an unknown date, one week ago ((b)(6) 2020), the patient¿s corticoid dose was 5 mg and she again experienced granuloma formation under her eyes and dose was increased to 7.5 mg.At the time of the report, the patient had not recovered, and the corrective treatment with corticoid and allopurinol was still ongoing.Outcome at the time of the report: induration was not recovered/not resolved.Granuloma formation was not recovered/not resolved.Migration of volyme was not recovered/not resolved.Edematous swelling was not recovered/not resolved.Tracking list: v.0 initial v.1 fu received on (b)(6) 2020 from the same reporter.Event swelling added.Suspect device implant dates, location, event onset date, location, outcome, and corrective treatment details were updated.V.2 fu received on (b)(6) 2020 from the same reporter.Coding of implant site swelling changed to implant site oedema.Patient demographics, medical history, past filler treatment, suspect device implant location, needle type, event onset date, location, outcome, severity, corrective treatment details and reporter causality were updated.V.3 fu received on (b)(6) 2020 from the same reporter.Patient demographic details updated.New suspect added.Suspects volume and location updated.Past and concomitant filler added.Corrective therapy details updated.V.4 fu received on (b)(6) 2020 from the patient.Concomitant filler, suspect device volume, location, injection technique, event location of granuloma and outcome were updated.Case was upgraded to serious.
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Manufacturer Narrative
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Pharmacovigilance comment: the serious events of oedema at implant site and granuloma skin and the non-serious event of induration at implant site were considered expected and possibly related to the treatments.Serious criteria includes multiple medical interventions to prevent permanent damage including hyaluronidase, antibiotics, antihistamines and repeated courses of steroids.The non-serious event of device dislocation was considered expected and possibly related to the treatment with restylane volyme and restylane defyne, and unexpected and unrelated to restylane refyne since restylane refyne was only administered to the lower face and could not have impacted the affected areas.The reporter only considered a causal relationship to the restylane defyne treatments.The non-serious event of nodule at implant site was considered expected and possibly related to the treatment with restylane defyne and unexpected and unrelated to restylane volyme and restylane refyne as no treatment was performed to the affected areas.The non-serious event of cutaneous contour deformity was considered unexpected and unrelated to the treatments.Alternative etiology include continuous hylase applications or long-term corticoid intake.The root cause for the events include product characteristics with known risks for delayed onset inflammatory reactions and low grade biofilm infections.An underlying dental infection might also have precipitated the inflammatory reaction.There was no biopsy or histopathological confirmation of granuloma reported.The case meets the seriousness criteria for expedited reporting to the regulatory authorities.Engineering evaluation (capa comment): 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.Manufacturer narrative: no potential quality issues have been identified in the manufacturing process of the specified batch, 17797-1.The batch is manufactured and released according to galderma quality management system.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on 30-jul-2020 by a physician which refers to a 54-year-old female patient.The patient had volume loss in cheek area, mentolabial folds and chin wrinkles.The patient's medical history included allergy to pollen, unspecified hairs, unspecified nuts and slightly low blood pressure.The patient had previously received treatment with unspecified ha filler to nasolabial folds and both lower eyelids around 3 to 5 years ago from the time of the report.According to the treatment report of the physician, the patient consulted the physician due to volume loss in her face for the first time on (b)(6)2020.After analysis, photo documentation, consulting and patient education, the treatment with hyaluronic acid was scheduled.On (b)(6)2020, the patient received treatment with 2 ml restylane volyme (lot s2192900005), to preauricular area (0.5 ml per side) and mid face (0.5 ml per side) due to volume loss in that area.The injections were performed with a blunt cannula in fan-shape pattern.Same day, on (b)(6)2020, the patient received treatment with 2.4 ml restylane defyne (s2190430008), 0.7 ml to each temporal areas and 0.3 ml to each cheek.The injections were performed with a pointed needle under use of bolus technique.The treatment was performed without problems or side effects.On (b)(6)2020 during a control visit with photo documentation, the patient was very satisfied with the results.On (b)(6)2020, the patient again received treatment with restylane defyne (lot 17667-1), 0.2 ml to chin dimples with a blunt cannula in linear technique with subcision and 0.4 ml to each pre-jowl sulcus using supra periosteal bolus technique and a pointed needle.The patient also received treatment with 1 ml restylane refyne (lot 17797-1) to corners of the mouth (0.4 ml per side) in fan-shape pattern and to the chin wrinkles each 0.1 ml of the product were administered with linear technique.The injections were performed with a pointed needle.On (b)(6)2020, the patient received treatment with 1 ml restylane fynesse (lot s2192240012) to upper lip with a pointed needle under use of blanching technique.On (b)(6)2020, at the control visit with again photo documentation, the patient again was very satisfied with the results.Because there were no conspicuities during course, the treatment was completed.95 days after restylane volyme, restylane defyne and 54 days after restylane refyne, restylane defyne injection, on (b)(6)2020, the patient experienced severe edematous swelling(implant site oedema) and palpable granuloma formation(granuloma skin) on lower eyelids, cheeks and pre-jowl sulci.Also experienced induration (implant site induration) especially in the areas that were injected with restylane volyme.The induration predominantly occurred on the right cheek and less pronounced on the left cheek, not at the injection site but above, on the orbital rim, above the tear trough and lower.Two days later in the chin areas that were injected with restylane defyne.The reporter especially worried about the migration of volyme(device dislocation) into the tear trough, which he did not inject into at all.On an unknown date in 2020, ultrasound examination revealed a clearly visible fluid depot, indurated and lying in the tissue like a sausage, although the product had been injected in a fan-shaped pattern.At the chin, only on the left side an induration and granuloma formation was observed.After the initial treatment of the cheeks, the product migrated to the lower eyelids (confirmed by ultrasound).Also a persistent intermittent delayed swelling pids occurred.On (b)(6)2020 a corrective treatment was performed with 60 iu of hylase [hyaluronidase] in tear trough and with 50-50 of a unspecified corticoid [corticosteroid nos].Also unspecified antihistamine and antibiotics were given.A decent improvement of the severe initial swelling was noticed.On (b)(6)2020, the next hylase treatment was performed due to increasing granuloma formation: 60 iu to the right lower eyelid, 20 iu to the left lower eyelid, 20 iu to the right sulcus, 40 iu to the left pre jowl sulcus.After the treatment an improvement was noticed.Further corrective treatment was given with antihistamines and antibiotics both not specified.Due to increasing swelling during course, the patient was also treated with a non specified corticoid from early (b)(6)2020 onwards starting with 50 mg of the product.The success of corrective treatment was only moderate, the eye area was always swollen and edema formation occurred.Corticoid therapy showed an improvement of the findings, but recurrent swellings of the lower eyelids on both sides remained.Granuloma formation in the eye area aggravated during course and also occurred now on her mentolabial fold.On (b)(6)2020, more hyaluronidase was applied as 10 units to each of two injection points at the left tear trough, 10 units to each of two injection points per side at the mentolabial folds, and 20 units to the left pre-jowl sulcus.On (b)(6)2020, next hyaluronidase treatment was performed, this time due to isolated granuloma on chin or sulcus, 30 units to left and 20 units to right pre-jowl sulcus, and further 30 units in total to two injection points at the left mentolabial fold.On around (b)(6)2020, the patient presented to another physician in a dermatologic clinic for a 2nd medical opinion as recommended by her attending physician.Since then she also took allopurinol [allopurinol].On (b)(6)2020, the left mentolabial fold and pre-jowl sulcus were treated with 30 units of hyaluronidase to each of 3 injection points.On (b)(6)2020, 90 iu hyaluronidase was injected to the left sulcus due to new granuloma formation.After 2-3 days there was a new induration and swelling, now much smaller, but still present.The patient also reacted to hylase with a swelling of the face and not only at the injection site, as the physician had observed otherwise.At the time of the report, the corrective treatment was still ongoing and the patient had not recovered.Severity of the adverse events was classified as moderate.The reporter assessed causality between the adverse events and restylane volyme and restylane defyne as possible.A biopsy was planned for mid (b)(6)2020.On 30-sep-2020, due to inconsistencies of the previously provided information, the reporter answered to requests for clarification by sending in the treatment documentation.He stated that on the reporting form, he erroneously had only mentioned the products that had provoked the adverse reactions in his opinion.As per follow up information received on 15-nov-2020, patient herself contacted the medical advisor by e-mail including a picture of the patient, the treatment report of the attending physician (reporter) and the treatment documentation (the latter had already been submitted on 30-sep-2020 by the reporting physician).On an unknown date, one week ago ((b)(6)2020), the patient´s corticoid dose was 5 mg and she again experienced granuloma formation under her eyes and dose was increased to 7.5 mg.At the time of the report, the patient had not recovered and the corrective treatment with corticoid and allopurinol was still ongoing.As per follow up information received on 18-dec-2020, the patient experienced mild swellings/nodule formation (implant site nodule) on the left orbital rim during further course and two more corrective treatments with hylase became necessary.On (b)(6)2020, each 5 iu hylase were administered to 2 injection points on the left orbital rim and 10 iu to a third injection point further to the left.On (b)(6)2020, 10 iu hylase were injected to one injection point on the orbital rim (treatment documentation attached).The patient was clearly doing better, but overall she still suffered from watery swelling of the lower eyelid and deepening of the tear trough(cutaneous contour deformity).According to the reporter probably caused by continuous hylase applications or long-term corticoid intake.As per follow up information received on 21-dec-2020, the patient presented on the same date to the reporter and again complained about a severe swelling of both lower eyelids, that aggravated after termination of corticoid intake.Hylase was injected into the sub-orbicularis oculi fat again on a trial basis in the hope that the swelling would improve.According to the reporting physicians statement a lower eyelid blepharoplasty was becoming increasingly likely.Outcome at the time of the report: granuloma formation was recovering/resolving.Edematous swelling was not recovered/not resolved.Induration was recovering/resolving.Migration of volyme was not recovered/not resolved.Nodule formation was recovering/resolving.Deepening of the tear trough was not recovered/not resolved.Tracking list: v.0 initial v.1 fu received on 01-sep-2020 from the same reporter.Event swelling added.Suspect device implant dates, location, event onset date, location, outcome and corrective treatment details were updated.V.2 fu received on 04-sep-2020 from the same reporter.Coding of implant site swelling changed to implant site oedema.Patient demographics, medical history, past filler treatment, suspect device implant location, needle type, event onset date, location, outcome, severity, corrective treatment details and reporter causality were updated.V.3 fu received on 30-sep-2020 from the same reporter.Patient demographic details updated.New suspect added.Suspects volume and location updated.Past and concomitant filler added.Corrective therapy details updated.V.4 fu received on 15-nov-2020 from the patient.Concomitant filler, suspect device volume, location, injection technique, event location of granuloma and outcome were updated.Case was upgraded to serious.V.5 fu received on 18-dec-2020 and 21-dec-2020 from the same physician.Events (nodule formation, deepening of the tear trough) added.Outcome of granuloma formation, induration and corrective treatment details of hylase updated.
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