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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Urticaria (2278); Shaking/Tremors (2515); Speech Disorder (4415); Swelling/ Edema (4577); Peripheral Edema (4578)

Event Type  Injury  

Manufacturer Narrative

Company comment:the serious expected event of anaphylactic reaction and the non-serious, expected events of face oedema, urticaria, and the unexpected events of oedema peripheral, tremor, tongue oedema and dysarthria were considered possibly related to the treatment.Serious criteria include the potential life-threatening condition which might require intervention to prevent permanent damage.The likely root cause include hypersensitivity reaction 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.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)(4).Is a spontaneous report sent on 30-mar-2022 by a physician concerning a (b)(6) year old female patient.Additional information was received on 31-mar-2022 from another physician.No information about medical history, concomitant medication or previous filler treatments had been provided.The patient denied history of allergies or cofactors on the day of the procedure.On unknown date, the patient received treatment with sculptra to an unknown location (unknown amount, lot number, injection technique and needle type).The sculptra injection was performed by a dermatologist from another city.Right after injection of sculptra, the patient experienced an anaphylactic reaction (anaphylactic reaction).She started experiencing face edema (face oedema) that evolved to generalized urticaria (urticaria), lower limb edema (oedema peripheral) and tremor (tremor).Later, the patient experienced tongue edema (tongue oedema) and difficulty speaking (dysarthria).The patient underwent prick test with plla extracts at 1:1 pure concentration and intradermal tests at 1:10 and 1:100 dilutions and the results were positive.Treatment for the adverse event was not reported.Outcome at the time of the report: anaphylactic reaction was unknown.Face edema was unknown.Generalized urticaria was unknown.Lower limb edema was unknown.Tremor was unknown.Tongue edema was unknown.Difficulty speaking was unknown.

• Brand Name: SCULPTRA
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 14057769
• MDR Text Key: 289879656
• Report Number: 9710154-2022-00024
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P030050/S034
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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: 03/30/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female