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

Lot Number UNKNOWN

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

Patient Problems Granuloma (1876); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious expected events of granuloma skin and mass at implant site were considered possibly related to the treatment.Serious criteria include the need for medical intervention and long standing event suggestive of permanent damage.The patient report contained limited information; time to onset and medical history were not provided.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering narrative: 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 (b)(6) 2020 by an adult female patient concerning herself.No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided.On an unknown date, the patient received treatment with sculptra (unknown amount, lot number, injection technique and needle type) at unknown location.Unknown time later, on an unknown date in 2019, the patient had granulomas (granuloma skin) in lower jaw and near nasal labial folds.The patient went to the injector and had examination of lumps (implant site mass), who said that they would go away.But year later, they were still there and very pronounced.On an unknown date, the patient had received unspecified treatment.Outcome at the time of the report: granulomas was not recovered/not resolved.Lumps was not recovered/not resolved.

• 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
• MDR Report Key: 10417611
• MDR Text Key: 210178174
• Report Number: 1000118068-2020-00031
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• 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

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2020
• Distributor Facility Aware Date: 08/06/2020
• Event Location: Other
• Date Report to Manufacturer: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability