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

Lot Number UNKNOWN

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

Patient Problems Paralysis (1997); Numbness (2415); Implant Pain (4561)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of facial paralysis, the non-serious events of pain and hypoaesthesia at implant site were considered expected and possibly related to the treatment with restylane volyme and unexpected, unrelated to the treatment with restylane lyft since no treatment was performed to affected area.Serious criteria included the need for medical intervention to prevent permanent damage.The likely root cause include nerve injury or compression of nerve following filler injection leading to events.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.Lot number was not reported and the product could not be verified.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)(6) is a spontaneous report sent on (b)(6) 2021 by a physician which refers to a female patient of an unknown age.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On an unknown date in (b)(6) 2021 (5 weeks ago), the patient received treatment with restylane volyme to correct deep nasolabial folds with an unspecified cannula and restylane lyft to lateral cheek with deep deposition along the cheek bone with unspecified needle (unknown amount, lot number, injection technique).The procedure was performed by reporting physician.Same day, on an unknown date in (b)(6) 2021, during injection in the right nasolabial fold, the patient felt a brief shock like pain(implant site pain) which radiated from the nasolabial fold to her upper right lip.That pain lasted only a few seconds.The physician paused, then continued with filler injection once pain was gone.Immediately after injection, the right upper lip droop/paresis(facial paralysis) was observed (more significant than the left).At first, the reporting physician believed it to be a lidocaine effect.So physician reassured patient and booked a follow up appointment with patient two weeks later.On an unknown date in 2021, at her follow up appointment the right upper lip droop persisted.The reporter believed some of the bulk of the restylane volyme in the nasolabial fold was impeding the function of zygomaticis major/minor and/or levator anguli oris/ levator labii superioris.The physician dissolved some of the filler in the nasolabial fold with hyaluronidase [hyaluronidase], as well as the depos on the zygomatic bone at the angle.On week later at follow up appointment, on an unknown date in 2021, there was some mild improvement in the droop and in her ability to raise upper right lip.But a clear asymmetry persisted.The patient also reported a small patch of numbness(implant site hypoaesthesia) on right upper lip 1 cm in diameter.On an unknown date in (b)(6) 2021 (this week), the physician saw patient and the paresis of the muscles that lift the right upper lip into a snarl continues.The reporter had photos from every follow up appointment.Outcome at the time of the report: upper lip droop/paresis was not recovered/not resolved.Brief shock like pain was recovered/resolved.Numbness was unknown.

• Brand Name: RESTYLANE LYFT
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 north freeway; fort worth, TX 76177
• MDR Report Key: 11789834
• MDR Text Key: 263477469
• Report Number: 9710154-2021-00027
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P040024/S073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2021
• 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