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

Lot Number 16886

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

Patient Problems Dry Eye(s) (1814); Itching Sensation (1943); Scarring (2061); Blurred Vision (2137); No Code Available (3191)

Event Date 08/01/2019

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on 19-dec-2019 by an other health professional which refers to a (b)(6)-year-old female patient.Additional information was also received from consumer.No information about medical history or history of allergies has been provided.The patient had previously received treatment with unspecified filler and botox on an unknown date.On (b)(6) 2019, the patient received treatment with 1 ml restylane-l (lot 16886) to tear trough (0.5 ml on each side) with microcannula and unknown technique.The patient also received treatment with botox [botox], unspecified dose on (b)(6) 2019 to crow's feet and glabella.Same day, on (b)(6) 2019, patient had immediate blurry vision (vision blurred) at night, so bad that she called the health care professional, who told her not to worry.The patient also reported a bump (implant site mass) under one of her eye and it went away.Now there was a depression under eye (implant site scar).1 day later, on (b)(6) 2019, when followed up with eye doctor, no treatment was received.The patient still had blurry vision and really dry eyes (dry eye) that were itchy in corners (implant site pruritus).She also reported that she never even saw any effect (device ineffective).It was reported that patient had visited her eye doctor 3 times since the symptoms started and the events were still ongoing.The patient had not received any treatment.Outcome at the time of the report: blurry vision was not recovered/not resolved.Itchy in corners was not recovered/not resolved.Dry eyes was not recovered/not resolved.Bump under eye was recovered/resolved.Depression under eye was not recovered/not resolved.Never even saw any effect was not recovered/not resolved.

• Brand Name: RESTYLANE-L
• 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: 9555511
• MDR Text Key: 183356306
• Report Number: 1000118068-2020-00002
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 16886
• 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: 01/06/2020
• Distributor Facility Aware Date: 12/19/2019
• Date Report to Manufacturer: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 40 YR