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

Lot Number 18151

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

Patient Problems Cellulitis (1768); Erythema (1840); Necrosis (1971); Pain (1994); Obstruction/Occlusion (2422); Pallor (2468); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious expected events of necrosis, cellulitis at implant site and vascular occlusion were considered possibly related to the treatment.Serious criteria include the need for multiple medical interventions.The non-serious expected events of erythema, pain and pallor at implant site were considered possibly related to the treatment.The potential root cause is the treatment procedural risk of intravascular or perivascular filler injection leading to vascular occlusion or vascular compression and its manifestations along with cellulitis at implant site.Contributory factors include injection in a vascular rich area, anatomical variations in vasculature associated with previous trauma given blanching and delayed capillary refill prior to treatment, and potential poor injection technique or overcorrection given the three syringes used for the procedure within potential areas of confined space in the forehead and temples.The restylane defyne was used off label.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.The reported lot number was valid.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 01-dec-2020 by a physician which refers to a (b)(6) female patient.Additional information was received on 03-dec-2020 from same reporter.The patient's medical history included depressed forehead scar.The patient had no known allergies.The patient does not take any concomitant medications.No information about previous filler treatments has been provided.On (b)(6) 2020, the patient received treatment with 3 syringes restylane defyne with lidocaine (lot 18151) to forehead using standard needle type and injection technique to depressed forehead scar.The restylane defyne was injected to forehead (off label use of device).4 days later, on (b)(6) 2020, the patient experienced mild redness (implant site erythema) and mild tenderness(implant site pain) on forehead.On 25-nov-2020, the patient reported to hcp.Hcp thought adverse event was related to the 0.1 ml injection placed in the left forehead in small aliquot injections under the horizontal scar on her forehead.Considering the very delayed and mild presentation and only 0.1 ml was injected in that area, hcp suspected cellulitis(implant site cellulitis).The patient was started on doxycycline [doxycycline], bactroban [mupirocin] and asked patient to send daily progress photos.On (b)(6) 2020, the patient returned to office for follow-up and a small amount of necrosis(implant site necrosis) was noted.Hcp also suspected occlusion(vascular occlusion).The hcp injected 0.5 ml hylenex [hyaluronidase] (150u/ml) diluted with 0.5ml lidocaine [lidocaine].It was reported that skin was blanchable (implant site pallor) with a cap refill of < 2 seconds prior to injection, so there was no change in that.The patient would return to hcp office on (b)(6) 2020.On 03-dec-2020, the photos were sent to case.Outcome at the time of the report: necrosis was recovering/resolving.Suspected occlusion was unknown.Cellulitis was unknown.Redness was unknown.Tenderness was unknown.Skin was blanchable was unknown.Restylane defyne was injected to forehead was recovered/resolved.

• Brand Name: RESTYLANE DEFYNE WITH LIDOCAINE
• 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: 11021223
• MDR Text Key: 222004520
• Report Number: 1000118068-2020-00046
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2022
• Device Lot Number: 18151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2020
• Distributor Facility Aware Date: 12/01/2020
• Event Location: Other
• Date Report to Manufacturer: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR