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

Lot Number 18768

Device Problems Malposition of Device (2616); Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Skin Discoloration (2074); Obstruction/Occlusion (2422); Pallor (2468); Swollen Lymph Nodes/Glands (4432); Easy Bruising (4558); Reaction to Medicinal Component of Device (4574); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious expected event of vascular occlusion was considered possibly related to the treatment.Serious criteria included the need for urgent medical care to prevent permanent damage.The non-serious expected events of bruising, swelling, pallor, discolouration, pustules, pain at implant site, injury associated with device and non-serious unexpected events of lymphadenopathy, poor peripheral circulation and livedo reticularis were considered possibly related to the treatment.The likely root causes include vascular injury and intravascular filler injection leading to vascular occlusion and its secondary effects.The potential root cause for implant site pustules includes injection procedure associated with inadequate aseptic technique.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacturer narrative: 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 21-may-2021 by a (b)(6) female patient (nurse practitioner) concerning herself.Additional information was received on 25-may-2021 from the same reporter.The patient had no significant medical history or any known allergies and was not taking any routine medications or products.The patient had not received the covid vaccine at the time of report.The patient had no vaccines or dental procedures in the 6-12 months prior to treatment.The patient did not have any illness the month prior to her injection.The patient had previously received treatment with restylane, juvaderm, botox and dysport on unknown dates.On (b)(6) 2021, during a training, the patient received treatment with an unknown amount of restylane defyne (lot 18768), approximately 3 mm to the right of the midline of chin with unknown needle using unknown technique.Same day of treatment, on (b)(6) 2021, the patient thought that the injector hit an artery(injury associated with device) and it turned out to be a vascular occlusion(vascular occlusion).The patient had a bruise(implant site bruising), that looked like purple blotches(implant site discolouration) and white blotches(implant site pallor) on her chin spreading to her marionette lines, oral commissure area, submental/neck area.It looked very mottled(livedo reticularis) with pain/hurts a lot/very sore(implant site pain).The patient also had swelling(implant site swelling) to her chin that was extending to her marionette lines and submental/neck area.The patient also had a swollen lymph node(lymphadenopathy) on her neck.The patient stated that she had a capillary refill of 4 seconds(poor peripheral circulation).The patient had also developed pustules(implant site pustules) in the chin area where the occlusion was.On an unknown date in (b)(6) 2021, the patient took vicodin [paracetamol/hydrocodone bitartrate] for pain and had 3 vials of hylenex [hyaluronidase] injected (1st dose on an unknown date in (b)(6) 2021, 2nd dose on (b)(6) 2021 and 3rd dose on (b)(6) 2021).The patient was also prescribed nitropaste [glyceryl trinitrate], bactrim [trimethoprim/sulfamethoxazole], hydrocolloid patched to face for pustules and arnica [arnica montana] for bruising.As of (b)(6) 2021, the bruising to chin, marionette lines area and submental/neck area was still there but was better and the patient no longer had pain.The patient still had swelling to chin, marionette lines and neck.Also, the swollen lymph node on neck was still there and the capillary refill was 3 seconds.Outcome at the time of the report: vascular occlusion was not recovered/not resolved.White blotches was not recovered/not resolved.Bruise was recovering/resolving.Purple blotches was not recovered/not resolved.Mottled was not recovered/not resolved.Swelling was not recovered/not resolved.Swollen lymph node was not recovered/not resolved.Pain/hurts a lot/very sore was recovered/resolved.Capillary refill of 4 seconds was recovering/resolving.Hit an artery was recovered/resolved.Pustules was not recovered/not 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
• 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 76177
• MDR Report Key: 11984630
• MDR Text Key: 267819125
• Report Number: 9710154-2021-00042
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P140029
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Lot Number: 18768
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• 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