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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Dizziness (2194); Discomfort (2330); Loss of consciousness (2418)

Event Date 04/03/2018

Event Type  Injury  

Event Description

Case (b)(4) is a spontaneous report sent on 27-jul-2018 by a consumer which refers to a female (b)(6). The patient's denied any significant medical history and reported no known allergies. Previous filler treatments were not reported. On (b)(6) 2018, the patient received treatment with an unknown amount of restylane refyne (lot unknown) to the tear troughs and an unknown amount of restylane defyne (lot unknown) to the cheeks with unknown needle and technique. The patient also received treatment with botox [botox] in the glabellar region on the same day ((b)(6) 2018). On the same day, (b)(6) 2018, the patient experienced flush(flushing) around the left eye and light glare, vision affected(glare). On an unspecified date in (b)(6) 2018, the patient experienced pressure behind eye(ocular discomfort) and was light headed, dizziness(dizziness). One month later, in (b)(6) 2018, the patient experienced blackouts (loss of consciousness). Treatment for the adverse event included injection of hyaluronidase [hyaluronidase] on a total of 3 dates: (b)(6) 2018 and 2 other unspecified dates. The patient also sought treatment at an emergency room (er) on two separate occasions, but the details of the treatment was not reported. The patient was directed to follow up with an otolaryngologist and neurologist for additional workup. Outcome at the time of the report: flush was not recovered/not resolved. Light glare, vision affected was not recovered/not resolved. Pressure behind eye was not recovered/not resolved. Light headed, dizziness was not recovered/not resolved. Blackouts was not recovered/not resolved.

• Brand Name: RESTYLANE DEFYNE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• MDR Report Key: 7783437
• MDR Text Key: 117136821
• Report Number: 1000118068-2018-00026
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2018
• Distributor Facility Aware Date: 07/27/2018
• Event Location: No Information
• Date Report to Manufacturer: 07/27/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 08/14/2018 Patient Sequence Number: 1