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

Lot Number 17060-2

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

Patient Problems Abrasion (1689); Bruise/Contusion (1754); Occlusion (1984); Skin Discoloration (2074); Skin Erosion (2075); Discomfort (2330); Numbness (2415); Pallor (2468); No Code Available (3191)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious expected event of vascular occlusion was considered possibly related to the treatments.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The non-serious, expected events of hypoaesthesia, pallor, discolouration, paraesthesia and bruising at the implant site, neuralgia and livedo reticularis and the unexpected events of ocular discomfort and purpura were considered possibly related to the treatments.Potential contributory factor include injection technique and intravascular injection leading to vascular occlusion.Both products were used off label.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering comment (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.Manufacturer comment: the reported lot number was valid.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 20-feb-2020 by another health professional which refers to a (b)(6)-year-old female patient.No information about medical history, concomitant medication, history of allergies has been provided.The patient had old filler (unspecified) to bilateral tear troughs dissolved with hyaluronidase 150 iu/ml on (b)(6) 2019 for cosmesis.On (b)(6) 2019, the patient received treatment with 0.5 syringe of restylane silk (lot 17060-2) to bilateral tear trough (0.3 to right and 0.2 syringe to left side) for deep support with needle using bolus injection technique.On (b)(6) 2019, the patient received treatment with 1 syringe restylane skinbooster vital lidocaine (lot 16860-1) superficially via cannula to the tear trough (0.5 syringe on each side) with unknown injection technique.Both products were off label use(off label use) at tear trough.Same day, on (b)(6) 2019, patient stated she felt right eye discomfort(ocular discomfort) and complete numbing (implant site hypoaesthesia) to the right side of the face immediately after injection of bolus but there was no visual impairment.Moments later, there was blanching (implant site pallor) to the right cheek and then travelling dusky purple vessels (implant site discolouration) to the lower right cheek and medial canthus leading up to forehead.All areas were injected with hyaluronidase [hyaluronidase] 150 iu/ml.Warm compress and warm blanket provided with digital massage to the right eye after consulting with the local ophthalmologist.The patient also received treatment with asa [acetylsalicylic acid], 325 mg, 2 tablets po, tadalafil [tadalafil], 20 mg po, rupal [rupatadine fumarate], 2 tabs po and minoxidil [minoxidil] 2.5 mg po.Nitropaste [glyceryl trinitrate] was applied to the right cheek.Intravenous infusion was initiated to the right dorsum hand, with 250 ml of normal saline [sodium chloride] at 1100 hrs.The local ophthalmologist organized ophthalmic testing.Testing revealed no eye injury, occlusion or any concerns to the patient.Upon return to the reporter office, patient occlusion (vascular occlusion) spread to mid, upper forehead and into the upper lip, gums to the right of the face.The patient was injected with hyaluronidase 1500iu/ml throughout these areas.Another 250 ml of normal saline was infused intravenously at 13:30 hrs.After approximately 2000iu of hyaluronidase was injected throughout the right side of the face over the course of 4 hours, the occluded areas were not resolving, therefore 6 ml of hyaluronidase 1500iu/ml was injected from within the mouth toward the infraorbital foramen on the right side of the face which finally resolved mottling(livedo reticularis) to the cheek, perioral and periorbital areas.Additionally, warm compress was applied, hyaluronidase 1500iu/ml was injected continuously into the right forehead, temple, glabella, upper lip and nasolabial fold beside the nostril until cap refill was sufficiently returned.One small skin tear occurred to the right cheek after wiping area with gauze.The patient right cheek was injected with hyaluronidase again.Time of filler occlusion approximately 09:10 hours, approximate time mottling started to dissipate 17:00 hours.That evening, the patient was injected with more hyaluronidase at approx 21:30 hours.In the morning of (b(6) 2019, the patient was injected with more hyaluronidase into the right cheek, nasolabial fold, gums, and periorbital areas at approx.09:00 hrs.Capillary refill was sufficient in all areas at this time.The patient had purpura(purpura) to right periorbital area, forehead and right nasolabial fold.Vision remains unaffected, however patient stated that there was a complete numbness to the right side of her face.The patient had localized nerve pain(neuralgia) to the right cheek for approximately 6 weeks post occlusion and she continued to have some numbness and paresthesia/tingling (implant site paraesthesia) sensation to the right cheek 8 weeks post occlusion.The patient was treated by the local general physician and was prescribed lyrica [pregabalin] for paresthesia.There was no necrosis of the visible tissue and bruising (implant site bruising) took approximately 4 weeks to subside.Outcome at the time of the report: occlusion was recovered/resolved.Eye discomfort was unknown.Complete numbing was not recovered/not resolved.Blanching was recovered/resolved.Dusky purple vessels was unknown.Purpura was unknown.Mottling was recovered/resolved.Paresthesia/tingling was not recovered/not resolved.Localized nerve pain was unknown.Bruising was recovered/resolved.Off label use was unknown.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6)2020 by a health professional, which refers to a 47-year-old female patient.The patient was healthy and had no allergies.The patient was not taking any concomitant medications.The patient had previously received treatment with tsrl and redensity on (b)(6)2014 to bilateral tear troughs, which was dissolved with hyaluronidase 150 iu/ml on (b)(6)2019 for cosmesis.On (b)(6)2019 , the patient received treatment with 0.5 syringe of restylane silk (lot 17060-2) to bilateral tear trough (0.3 to right and 0.2 syringe to left side) for deep support with needle using bolus injection technique.Restylane silk was off label use(off label use) at tear trough.On (b)(6)2019 , the patient received treatment with 1 syringe restylane skinbooster vital lidocaine (lot 16860-1) superficially via cannula to the cheeks (0.5 syringe on each side) with unknown injection technique.Ten minutes later, on (b)(6)2019 , the patient noted mottling (livedo reticularis) on upper right lip, cheek up to eye, right nose, right forehead.Seven (7) hours later, on (b)(6)2019 , the patient experienced 2 ulcerated erosion (implant site ulcer) 1 cm at right cheek.Same day, on (b)(6)2019 , patient stated she felt right eye discomfort(ocular discomfort) and complete numbing (implant site hypoaesthesia) to the right side of the face immediately after injection of bolus but there was no visual impairment and right upper teeth, slight pinch on right lower eyelid after bolus at tear trough.Moments later, there was blanching (implant site pallor) to the right cheek and then travelling dusky purple vessels (implant site discolouration) to the lower right cheek and medial canthus leading up to forehead.All areas were injected with hyaluronidase [hyaluronidase] 150 iu/ml.Warm compress and warm blanket provided with digital massage to the right eye after consulting with the local ophthalmologist.The patient also received treatment with asa [acetylsalicylic acid], 325 mg, 2 tablets po, tadalafil [tadalafil], 20 mg po, rupal [rupatadine fumarate], 2 tabs po and minoxidil [minoxidil] 2.5 mg po.Nitropaste [glyceryl trinitrate] was applied to the right cheek.Intravenous infusion was initiated to the right dorsum hand, with 250 ml of normal saline [sodium chloride] at 1100 hrs.The local ophthalmologist organized ophthalmic testing.Testing revealed no eye injury, occlusion or any concerns to the patient.Upon return to the reporter office, patient occlusion (vascular occlusion) spread to mid, upper forehead and into the upper lip, gums to the right of the face.The patient was injected with hyaluronidase 1500iu/ml throughout these areas.Another 250 ml of normal saline was infused intravenously at 13:30 hrs.After approximately 2000iu of hyaluronidase was injected throughout the right side of the face over the course of 4 hours, the occluded areas were not resolving, therefore 6 ml of hyaluronidase 1500iu/ml was injected from within the mouth toward the infraorbital foramen on the right side of the face which finally resolved mottling to the cheek, perioral and periorbital areas.Additionally, warm compress was applied, hyaluronidase 1500iu/ml was injected continuously into the right forehead, temple, glabella, upper lip and nasolabial fold beside the nostril until cap refill was sufficiently returned.One small skin tear(skin abrasion) occurred to the right cheek after wiping area with gauze.The patient right cheek was injected with hyaluronidase again.Time of filler occlusion approximately 09:10 hours, approximate time mottling started to dissipate 17:00 hours.That evening, the patient was injected with more hyaluronidase at approx 21:30 hours.In the morning of (b)(6)2019 , the patient was injected with more hyaluronidase into the right cheek, nasolabial fold, gums, and periorbital areas at approx.09:00 hrs.Capillary refill was sufficient in all areas at this time.The patient had purpura(purpura) to right periorbital area, forehead and right nasolabial fold.Vision remains unaffected, however patient stated that there was a complete numbness to the right side of her face.The patient had localized nerve pain(neuralgia) to the right cheek for approximately 6 weeks post occlusion and she continued to have some numbness and paresthesia/tingling (implant site paraesthesia) sensation to the right cheek 8 weeks post occlusion.The patient was treated by the local general physician and was prescribed lyrica [pregabalin] for paresthesia.There was no necrosis of the visible tissue and bruising (implant site bruising) took approximately 4 weeks to subside.The patient still experiencing numb in upper right dental area to the foreman, but there was no permanent injury to the patient.The patient had infra-orbital nerve loss function till now.There was no need for medical intervention to prevent any impairment to body function other than the procedures the nursing staff did in office when the event occurred.Discrepancy: in the follow-up report, the seriousness criteria of permanent impairment of a body function/body structure was checked and they noted the left infra-orbital nerve loss sensation that was not yet recovered.Outcome at the time of the report: occlusion was recovered/resolved.Complete numbing was not recovered/not resolved.Paresthesia/tingling was not recovered/not resolved.Eye discomfort was recovered/resolved.Blanching was recovered/resolved.Dusky purple vessels was recovered/resolved.Purpura was recovered/resolved.Mottling was recovered/resolved.Localized nerve pain was recovered/resolved.Bruising was recovered/resolved.Ulcerated erosion was recovered/resolved.Small skin tear was recovered/resolved.Off label use was recovered/resolved.Tracking list: v.0 initial v.1 fu received on (b)(6)2020 from the reporting hcp: past filler treatment, event severity, outcome, reporter causality and corrective treatment details were updated.Event of ulcer and skin laceration added.

Manufacturer Narrative

Pharmacovigilance comments: the serious expected event of vascular occlusion was considered possibly related to the treatments.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The non-serious, expected events of hypoaesthesia, paraesthesia, pallor, discolouration, ulcer and bruising at the implant site, neuralgia and livedo reticularis and the unexpected events of ocular discomfort and purpura were considered possibly related to the treatments.Potential contributory factor include injection technique and intravascular injection leading to vascular occlusion.Restylane silk was used off label.The non-serious event of skin abrasion was considered unexpected and unrelated to the treatments as it occurred after wiping the area with gauze.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering comment (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.Manufacturer comment: no potential quality issues have been identified in the manufacturing process of the specified batch 17060.The batch is manufactured and released according to galderma quality management system.

• Brand Name: RESTYLANE SILK
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• MDR Report Key: 9771091
• MDR Text Key: 195939768
• Report Number: 9710154-2020-00037
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P040024/S072
• 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: 03/05/2020

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 Lot Number: 17060-2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RESTYLANE SKINBOOSTER VITAL LIDOCAINE; RESTYLANE SKINBOOSTER VITAL LIDOCAINE
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR