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  

Manufacturer Narrative

Manufacturer narrative: the reported lot number was valid.Capa comment: 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.Pharmacovigilance comment: the serious, expected event of vision blurred, the non-serious, expected events of pruritus, mass, scar at implant site, device ineffectiveness, and non-serious, unexpected event of dry eye were considered possibly related to the treatment.Serious criteria include the disability associated with blurred vision for an extended period.Potential contributory factors include injection technique and local spread of the concomitant botulinum toxin treatment.No treatment was required and the eye disorders might resolve as the toxin effect subsides.The case meets the criteria for expedited reporting to the regulatory authorities.

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 form 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 healthcare 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
• Manufacturer (Section G): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• Manufacturer Contact: amy poteate ; 14501 north freeway; fort worth, TX 76177 ; 8175615353
• MDR Report Key: 9555471
• MDR Text Key: 189440258
• Report Number: 9710154-2020-00004
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040024/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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
• Date Manufacturer Received: 12/19/2019
• 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): Disability
• Patient Age: 40 YR