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

Lot Number 19269

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

Patient Problems Ecchymosis (1818); Hematoma (1884); Obstruction/Occlusion (2422); Pallor (2468); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious event of vascular occlusion and the non-serious events of haematoma, bruising and pallor at implant site were considered expected and possibly related to the treatment.The likely root cause include intravascular filler injection leading to vascular occlusion and its manifestations.Restylane defyne was used off label.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 17-nov-2021 by an other health care professional which refers to a (b)(6) female patient.The patient's medical history included hormonal acne.Concomitant medications included spironolactone [spironolactone] for hormonal acne, allegra [fexofenadine hydrochloride] and adderall [amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate].The patient had no known allergies.The patient had previously received treatments with unspecified filler to chin and botox.The patient had no vaccines or dental procedures in the last 6 to 12 months or any illness in the month prior to treatment.On (b)(6) 2021, the patient received treatment with 0.1 ml restylane defyne (lot 19269) to lips (unknown injection technique and needle type).The restylane defyne was injected to lips (off label use of device).On (b)(6) 2021, the patient started to develop a hematoma (implant site haematoma).The hcp assessed it as an occlusion (vascular occlusion) and injected three vials of hylenex [vorhyaluronidase alfa] into the area.After leaving it for 30 minutes, the patient was having bruising (implant site bruising) outside the lip moving to the nasolabial fold with paleness (implant site pallor) to the lip.On (b)(6) 2021, the symptoms resolved.On (b)(6) 2021, the medical director was to follow up with the patient.Outcome at the time of the report: hematoma was recovered/resolved.Bruising was recovered/resolved.Paleness was recovered/resolved.Occlusion was recovered/resolved.Restylane defyne was injected to lips was recovered/resolved.

• Brand Name: RESTYLANE DEFYNE
• 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: 12977061
• MDR Text Key: 282979413
• Report Number: 1000118068-2021-00039
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Lot Number: 19269
• 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: 12/10/2021
• Distributor Facility Aware Date: 11/17/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADDERALL; ALLEGRA; SPIRONOLACTONE
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female