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

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

Patient Problems Cough (4457); Angioedema (4536); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious event of angioedema was considered expected and possibly related to the treatment.Serious criteria included the need for multiple medical interventions to prevent permanent damage.The non-serious, expected events of implant site oedema and paraesthesia oral, and the unexpected event of cough were considered possibly related to the treatment.The likely root cause for the reported events is hypersensitivity reaction leading to angioedema with secondary manifestations, but no etiological tests were reported.The case meets the criteria for expedited reporting to the regulatory authorities.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.Lot number was not reported.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 03-nov-2020 by a physician which refers to a patient (unknown age and gender).No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On an unknown date, the patient received treatment with restylane to unknown location for an unknown indication (unknown amount, lot number, injection technique and needle type).Same day (on an unknown date), at the end of injection procedure with restylane, the patient experienced lip edema(implant site oedema), local paresthesia on the mouth (paraesthesia oral), cough(cough) and localized angioneurotic edema(angioedema).As a corrective treatment, the patient received oxygen therapy and underwent cardiac monitoring.The patient also received adrenalin [epinephrine] 0.3 mg via intramuscular route in the vast lateral region of the thigh, (it was not necessary to repeat the dose), flebocortid [hydrocortisone sodium succinate], 50 to 200 mg per kg per day, every 4 hours.On an unknown date, the patient was discharged after 12 hours with the use of unspecified antihistamine and unspecified corticosteroids [corticosteroid nos] for 4 days.Outcome at the time of the report: localized angioneurotic edema was unknown.Lip edema was unknown.Local paresthesia on the mouth was unknown.Cough was unknown.

• Brand Name: RESTYLANE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 10877528
• MDR Text Key: 217932883
• Report Number: 9710154-2020-00094
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040024
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: No
• 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