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

Lot Number A8137

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

Patient Problems Rash (2033); Swelling (2091); Dizziness (2194); Urticaria (2278); No Code Available (3191)

Event Date 10/01/2019

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 event of anaphylactic reaction was considered expected and possibly related to the treatment.Serious criteria included the need for urgent medical care, and treatment with epinephrine, steroids and anti-histamines.The non-serious expected events of dizziness, pruritus, rash and hives and unexpected event of peripheral swelling were considered possibly related to the treatment and are consistent with the diagnosis of anaphylaxis.Potential contributory factors include concomitant treatments with botulinum toxin and lidocaine.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 07-oct-2019 by a physician which refers to a female aged (b)(6) years.The patient had no significant medical history and no known drug allergy.The patient was not on any routine medications.The patient had not received any filler treatments in the past.Concomitant treatment included lidocaine [lidocaine] and botox [botox] injection on (b)(6) 2019.On (b)(6) 2019, the patient received treatment with 8 ml total of sculptra aesthetic (lot a8137) mixed with lidocaine to cheek area, jawline and right temple (unknown injection technique and needle type) for an unknown indication.15 minutes later, on (b)(6) 2019, the patient experienced lightheaded (dizziness).The healthcare professional assisted the patient into a lying down position.Soon after, the patient started having and itching (pruritus) and rash (rash) that turned into hives (urticaria), spread all over her body.The patient also had swollen hands (peripheral swelling).The patient was injected with kenalog [triamcinolone acetonide] intramuscularly by healthcare professional and also given oral benadryl [diphenhydramine hydrochloride].The patient went to emergency room and was told she was having an anaphylactic reaction (anaphylactic reaction).The patient was given epinephrine [epinephrine] and unspecified steroids.On (b)(6) 2019, the injecting physician spoke with the patient who reported that she was still experiencing itching and rash.Outcome at the time of the report: anaphylactic reaction was not recovered/not resolved.Lightheaded was recovered/resolved.Itching was not recovered/not resolved.Swollen hands was recovered/resolved.Hives was not recovered/not resolved.Rash was not recovered/not resolved.

• Brand Name: SCULPTRA AESTHETIC
• 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: 9215417
• MDR Text Key: 170792894
• Report Number: 9710154-2019-00092
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030050/S2
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: A8137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2019
• 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
• Patient Age: 65 YR