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

Lot Number 87119

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

Patient Problems Autoimmune Disorder (1732); Inflammation (1932); Scar Tissue (2060); Nodule (4551)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6) comment: the serious events of nodule and scar at implant site and the non-serious event of inflammation at implant site were considered expected and possibly related to the treatment.Serious criteria include the need for surgical intervention and permanent damage.The potential root cause include a foreign body reaction to the product in the local tissue.Potential contributory factor for scar at implant site include surgical intervention.The non-serious event of sjogren's syndrome was considered unexpected and unrelated to treatment.Alternative etiology include unknown/undisclosed autoimmune disorder.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacturer narrative: routine investigations have been performed and indicate a possible involvement of the product.The type of incident is expected following use of the product.The reported lot number was not a valid lot number for a galderma product.A follow up will be performed.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 (b)(6) 2021 by a physician which refers to a female patient who was (b)(6) at the time event onset.The patient had no known medical history or allergies.The patient had previously received treatment with voluma.On (b)(6) 2018, the patient received treatment with 7 ml sculptra aesthetic (lot 87119) to cheeks, temples, medial and lateral zygomatics using unknown needle type and injection technique.The 7 ml sculptra aesthetic was diluted with 1 ml lidocaine [lidocaine].Immediately after injection, on (b)(6) 2018, the patient experienced inflammation(implant site inflammation).Unknown time later, on an unknown date, the patient also developed sjogren's disease(sjogren's syndrome) after her treatment in 2018.Unknown time later, on an unknown date in 2019, the patient had experienced potential delayed nodule/thickening may be potential nodule(implant site nodule) to her right temple area of the forehead from sculptra aesthetic treatment back in 2018, which was resected later.The patient now had a tiny scar/puncture wound(implant site scar) on the right forehead.The patient had reported a thickening to her right inferior cheek to the buccal part (almost mid-face) that recently became more noticeable and was growing more, having more of an effect on her work and sleep.The hcp thought thickening might be potential nodule, except that it was a tubular 2-3 cm thickening and was not circular and was not able to hold it.On an unknown date, the patient had contacted the hcp, who offered to break up the area of thickening with saline using a cannula and also suggested treatment with radiofrequency.Outcome at the time of the report: potential delayed nodule/thickening may be potential nodule was not recovered/not resolved.Tiny scar/puncture wound was not recovered/not resolved.Inflammation was not recovered/not resolved.Sjogren's disease was not recovered/not resolved.Tracking list: v.0 initial v.1 fu received on (b)(6) 2021 from the same reporter.Case upgraded to serious.Events (inflammation, sjogren's disease, tiny scar/puncture wound) added.Patient demographics, concomitant treatment, suspect device implant date, location, volume, lot number, expiry date, onset date, verbatim, location, outcome of event implant site nodule and surgical intervention details updated.

• Brand Name: SCULPTRA AESTHETIC
• 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: 11890777
• MDR Text Key: 266063215
• Report Number: 9710154-2021-00034
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Lot Number: 87119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/26/2021
• 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): Required Intervention; Disability
• Patient Age: 46 YR