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

Lot Number 16452

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

Patient Problems Malaise (2359); Loss of consciousness (2418); Pallor (2468); Respiratory Failure (2484)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

Engineering evaluation: 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.Restylane defyne is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.Manufacturer comment: the reported lot number was valid.Pharmacovigilance comment: the serious events of loss of consciousness and respiratory arrest and the non-serious events of malaise and pallor were considered unexpected and possibly related to the treatment.Serious criteria included life-threatening events and the need for urgent medical intervention with an epi-pen.The patient refused to go to the emergency room against medical advice.Potential etiologies include anaphylactic reaction to the treatment given medical history of hypersensitivity reactions to other unknown fillers and exposures that require carrying an epi-pen, and immediate response to the epinephrine used to treat the current events.Potential alternative etiologies include anaphylactic reaction to another exposure, syncope, vasovagal episode and seizure.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 (b)(6) 2019 by a nurse which refers to a caucasian female patient in her 50s.The patient medical history included reactions to unspecified fillers and other things, passed out (five years ago) which required the use of an epipen.This was why the patient had an epipen with her during the latest injection.The patient had previously received treatment with dysport twice on an unknown date (reported as more than three months ago) and stopped on (b)(6) 2019 without any incident.The patient also had received treatment with unspecified fillers in the past.On (b)(6) 2019, the patient received treatment with 0.3 to 0.4 ml restylane defyne (lot number 16452) to marionette lines following injection in nasolabial folds with unknown needle and technique.On (b)(6) 2019, 10 to 15 minutes into the treatment procedure, the patient was not feeling well (malaise) and appeared pale (pallor).The health care professional (hcp) stopped the injection, provided water and had the patient lied down.The patient reported that she had ben dieting and the hcp thought this could be related.After lied down, the patient stopped breathing (respiratory arrest) and eyes rolled back in head and became unresponsive (loss of consciousness).It was reported that the patient had passed out in the past but had not actually stopped breathing.On (b)(6) 2019, the patient was injected with an epipen [epinephrine] in the thigh and regained consciousness.The hcp called 911 but by the time they arrived the episode was over and the patient declined to go to the emergency room, which was what the hcp had advised.The hcp then advised the patient to contact her pcp to report the incident, and stated that she would not be injecting her with fillers in the future.Furthermore, the patient was observed for an hour after the injection.Outcome at the time of the report: eyes rolled back in head and became unresponsive was recovered/resolved.Became pale was recovered/resolved.Did not feel well was recovered/resolved.Stopped breathing was recovered/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
• 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: 8456632
• MDR Text Key: 140021120
• Report Number: 9710154-2019-00015
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/31/2020
• Device Lot Number: 16452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening