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

Lot Number 17328

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

Patient Problems Foreign Body Reaction (1868); Scar Tissue (2060)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Pharmaco-vigilance comments: the serious events of foreign body reaction and scar were considered expected and related to the treatment with restylane lyft with lidocaine.Serious criteria include the need for surgical intervention and permanent damage.The serious expected event of foreign body reaction was considered related to the treatment with restylane defyne and the serious, expected event of scar was considered unrelated to the treatment with restylane defyne as no excision was performed in that treatment area.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.Manufacturing narrative: the reported lot number was valid.

Event Description

Case reference number: (b)(4) is a spontaneous report sent on 19-oct-2020 by a physician, which refers to a patient of a (b)(6)-year-old female patient.The patient's medical history included guillain-barre syndrome and allergy to pcn, sulfa, codeine, dilantin, tetanus.Concomitant treatments included progesterone [progesterone], prozac [prozac] and thyroid [thyroid].The patient had previously received treatment with juvederm to cheeks and nasolabial folds on an unknown date in another office.On (b)(6) 2020, the patient received treatment with 1 ml restylane lyft with lidocaine (lot#: 17328) to upper cheeks and 1 ml restylane defyne (lot 16757) to perioral area, and chin with unknown needle type and injection technique.On an unknown date in jun-2020, the patient experienced delayed onset issue/foreign body giant cell reaction to filler material/granuloma.On 06-oct-2020, the excised specimen was received.The details of dermatopathology report of 07-oct-2020 were as follows: specimen site was left inferior medial malar cheek; gross description: received in formalin were 4 fragment of skin and yellow fatty tissue measuring 3.2x2x1 cm in aggregate.The surgical margins were inked blue.Representative section were submitted.1b.Bom/mtr.Microscopic description: slides examined.The specimen sent was diagnosed as foreign body giant cell reaction to filler material/granuloma(foreign body reaction), excised.No malignancy seen.On (b)(6) 2020, the patient was seen in hcp office, and received treatment with 60 units of hyaluronidase [hyaluronidase] with good resolution.Outcome at the time of the report: scar was not recovered/not resolved.Delayed onset issue/foreign body giant cell reaction to filler material/granuloma was recovered/resolved with sequelae.Tracking list: v.0 initial; v.1 fu received on 27-oct-2020 from the same reporter: case upgraded to serious.Event scar added.Event coding updated to foreign body reaction from adverse event.Patient demographics, medical history, past filler, concomitant medication, suspect device implant location, event severity, location, outcome, reporter causality and corrective treatment details were updated.

• Brand Name: RESTYLANE LYFT 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: 10826117
• MDR Text Key: 217651579
• Report Number: 1000118068-2020-00044
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Lot Number: 17328
• 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: 11/11/2020
• Distributor Facility Aware Date: 10/27/2020
• Event Location: Other
• Date Report to Manufacturer: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 72 YR