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

Lot Number UNKNOWN

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

Patient Problems Swelling (2091); No Code Available (3191)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious expected event of mass at implant site was considered possibly related to the treatment.Serious criteria include the need for medical intervention to prevent potential permanent damage since the visible lump persisted for several months and would likely be harder to treat.A steroid injection did not improve the defect.The patient was unable to obtain the necessary treatment for the reported lump for several months due to the covid-19 pandemic.The non-serious expected event of swelling at implant site was considered possibly related to the treatment.The case meets the criteria for expedited reporting to the regulatory authorities.Follow-up information will be requested.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.Manufacturing narrative: lot number was not reported.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 19-jul-2020 by an (b)(6)-year-old female patient who reports her own case.The patient medical history included chronic lymphocytic leukaemia, osteoarthritis.The patient has no allergies.Concomitant treatments included multivitamin [multivitamin] by mouth daily since 2010 for nutritional support, aleve [aleve] one to two tablet occasionally when needed since 2015 for osteoarthritis and joint pain.The patient had previously received treatment with voluma in lips, nasolabial folds and marionette lines, several injections, from 2018 to 2019, one injection of dysport in 2019, several injections of botox from 2012 to 2019 for cosmetic indication and experienced no adverse event.The patient had also received 2 vials of sculptra aesthetic on (b)(6) 2019 to cheeks and temples.On (b)(6) 2019, the patient received treatment with 2 vials of sculptra aesthetic (unknown lot number, injection technique and needle type) to temples and cheeks.Same day, immediately after the injection, on (b)(6) 2019, the patient experienced swelling(implant site swelling) in right eye tear trough and which resolved by (b)(6) 2020.Unknown time later, by the end of (b)(6) 2019, the patient had experienced a hard visible lump(implant site mass) below the right eye just above the cheekbone.The patient had religiously followed after care instructions.On (b)(6) 2020, patient received corrective treatment with injection of steroid mixture to dissolve the lump, which was not effective.The patient had an appointment with hcp on (b)(6) 2020 to address the event further but it was cancelled due to covid-19.Outcome at the time of the report: hard visible lump was not recovered/not resolved.Swelling was recovered/resolved.Tracking list: v.0 initial.V.1 fu received on 05-aug-2020 from the same reporter.Case upgraded to serious.Event swelling added.Patient demographics, medical history, past filler treatment, concomitant medications, suspect device volume and location were updated.

• Brand Name: SCULTRA 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 ; 9615146
• MDR Report Key: 10419882
• MDR Text Key: 207998575
• Report Number: 9710154-2020-00067
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030050/S002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/18/2020
• 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
• Patient Age: 65 YR