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

Lot Number 17698

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

Patient Problems Erythema (1840); Pain (1994); Skin Discoloration (2074); Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious expected adverse event of vascular compression was considered possibly related to the two suspect treatments.Serious criteria include the need for repeated medical intervention.The non-serious expected adverse events of implant site discolouration, erythema, as well as the non-serious unexpected adverse event of gingival pain were also considered possibly related to the two suspect treatments.The non-serious adverse event of injection site scab, which is unexpected with restylane-l and expected with restylane lyft with lidocaine, and the non-serious unexpected adverse event of livedo reticularis were also considered possibly related to the two above-mentioned suspect treatments.The restylane-l was used for an unapproved indication (off label).Potential contributory factors may include injection of filler in the vicinity of blood vessel leading to vascular compression and its manifestations.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: 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 number was valid.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 08-jul-2020 by nurse and which refers to a (b)(6) year-old female patient.The patient had no known medical history and allergies.The patient does not take any concomitant medication.No information about previous filler treatments has been provided.On (b)(6) 2020, the patient received treatment with 1 ml restylane-l (lot 17698), 0.5 ml in each tear trough with insulin/bd syringe needle on periosteum with unknown injection technique.The restylane-l was injected to tear trough (off label use).The patient also received treatment with 1 ml restylane lyft with lidocaine (lot 17691), 0.5 ml in each cheek using 29 gauge needle with unknown injection technique.Same day, on (b)(6) 2020, the patient experienced active occlusion/compression(vascular compression), red(implant site erythema) and mottling (livedo reticularis) at cheek, nose and tear trough.Same day patient was treated with 1 vial of hylenex [hyaluronidase], medrol [methylprednisolone], asa [acetylsalicylic acid] and nitro [glyceryl trinitrate].Also used warm compresses and the patient improved.Still some mottling was there.On (b)(6) 2020, the patient was again treated with 1 vial of hylenex, viagra [sildenafil citrate] and valtrex [valaciclovir hydrochloride], along with hyperbaric system, and improved.On (b)(6) 2020, the patient was again treated with 2.5 vials of hylenex, and improved.As per follow up information received on 10-jul-2020, the hcp reported that the events were resolving with hylenex treatment.The patient still had discoloration(implant site discolouration).Hcp questioned if that was normal.Seven (7) days later, on (b)(6) 2020, the patient experienced scab (injection site scab) at unknown location and experienced gum pain/gum sensitivity(gingival pain).Outcome at the time of the report: active occlusion/compression was recovering/resolving.Discoloration was recovering/resolving.Compression was recovering/resolving.Scab was recovering/resolving.Gum pain/gum pain/gum sensitivity was not recovered/not resolved.Red was recovering/resolving.Mottling was recovering/resolving.Restylane-l was injected to tear trough was recovered/resolved.Tracking list: v.0 initial.V.1 fu received on 10-jul-2020 from the same reporter: event (discoloration) added.Outcome updated.V.2 fu received on 27-jul-2020 from the same reporter.Event coding of vascular occlusion changed to vascular compression.Events (red, mottling, scab, gum pain/sensitivity) added.Suspect device restylane lyft with lidocaine added.Patient demographics, suspect device implant date, volume, needle type, lot number, corrective treatment details were updated.Case was upgraded to serious due to the required medical intervention.

• 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
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, tx ; 9615146
• MDR Report Key: 10350971
• MDR Text Key: 207912828
• Report Number: 9710154-2020-00065
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 07/31/2020

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: Health Professional
• Device Expiration Date: 09/30/2022
• Device Lot Number: 17698
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR