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

Lot Number 0J48D1

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Angioedema (4536); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

Company comment:the serious events of angioedema, hypersensitivity at implant site and pharyngeal oedema and the non-serious events of swelling and erythema at implant site were considered expected and possibly related to the treatment.Serious criteria included the need for urgent medical care including medical intervention with adrenaline to prevent a life threatening condition or permanent damage.The likely root cause include the patient's hypersensitivity to the product.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: routine investigations have been performed and indicate a possible involvement of the product.The reported lot number was valid and verified the reported product.No previous medical complaints have been reported on the specified lot number.However, a repeated batch record review will be conducted to exclude a non-conforming product.

Event Description

(b)(4) is a spontaneous report sent on 26-nov-2021 by a physician concerning a (b)(6) female patient.Additional information was received on (b)(6) 2021 from the same reporter.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On (b)(6) 2021, the patient received treatment with sculptra (lot 0j48d1) to face (unknown amount, injection technique and needle type).On (b)(6) 2021, after receiving sculptra injection, while returning home, the patient experienced allergic crisis (implant site hypersensitivity).The patient went to the hospital and was under observation.The patient experienced angioedema (angioedema), face swelling (implant site swelling), red skin stains (implant site erythema) and throat closed (pharyngeal oedema) as reported.On (b)(6) 2021, the patient received corrective treatment with adrenaline [epinephrine] and an unspecified corticoid [corticosteroid nos].On (b)(6) 2021, the patient was discharged from the hospital observation and was already at home.The patient's hospitalization lasted 8 hours.On (b)(6) 2021, the patient had a medical appointment with an allergist who requested some lab tests and oriented the patient to continue using corticoid until the acknowledge of tests results.At the time of report, the patient was still using corticoid.The reporting physician informed that the patient was stable and recovering.Outcome at the time of the report: angioedema was recovering/resolving.Allergic crisis was recovering/resolving.Swelling was recovering/resolving.Red skin stains was recovering/resolving.Throat closed was recovering/resolving.Tracking list: v.0 initial v.1 fu received on 30-nov-2021 from the same reporter: duration of hospitalization, outcome of events, corrective treatment and laboratory test details were updated.

• Brand Name: SCULPTRA
• 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: 12940206
• MDR Text Key: 286121186
• Report Number: 9710154-2021-00076
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030050S002
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Lot Number: 0J48D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• 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: 42 YR
• Patient Sex: Female