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

Lot Number 1J0996

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

Patient Problems Purulent Discharge (1812); Inflammation (1932); Skin Infection (4544); Nodule (4551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious events of nodule and infection at implant site and acne cystic and the non-serious events of inflammation at implant site and purulent discharge were considered expected and possibly related to the treatment.Serious criteria include the need for multiple medical and surgical interventions to prevent permanent damage.Potential root cause include injection procedure associated with inadequate aseptic technique.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was not a valid lot number for a galderma product.A follow up will be performed to obatin the lot number.The currently performed routine investigations are considered adequate but a batch record review will be requested if provided in order to rule out a non-conforming product.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 17-aug-2021 by a physician which refers to a (b)(6) year-old female patient.Additional information was received on 20-aug-2021 and 24-aug-2021 from same reporter.The patient was not pregnant and breastfeeding.No information about medical history, concomitant medications or history of allergies has been provided.The patient had previously received treatment with sculptra in 2020 (one year ago).At that time, the patient experienced nodules in the pre ear region that improved six months after.On an unknown date in (b)(6) 2021 (45 days ago), the patient received treatment with 10 ml sculptra (lot 1j0996) to the lower third of face using an unspecified needle and cannula with unknown injection technique.The sculptra which was diluted at the time of injection.Approximately 30 days later, on an unknown date in (b)(6) 2021, the patient experienced inflammatory (implant site inflammation), nodule/cystic/suppurative nodule (implant site nodule), an infected (implant site infection) nodule near the mandible angle, which drained a much of pus/ purulent secretion (purulent discharge).The patient experienced events in the left mandible region.On an unknown date in (b)(6) 2021, the patient underwent a medical appointment and as a corrective treatment the physician performed a drainage and prescribed azithromycin [azithromycin].The patient returned after two days and received a new drainage.Azithromycin was used for 7 days, without improvement.On (b)(6) 2021, the patient returned to a medical appointment and another drainage was performed.The physician informed that she was experiencing grade 4 acne (acne cystic), similar to a cystic/suppurative nodule with drainage of a lot of purulent secretion.On an unknown date in (b)(6) 2021, an unspecified gram culture was collected and sent to a lab and the result was negative.The patient was also prescribed with cephadroxil [cefadroxil] was.Currently, the patient was using cephadroxil and at the time of report she was in the 7 day of treatment.As a corrective treatment, the patient received antibiotic and systemic corticosteroids, evolving with local drainage.At the time of the report, the patient was without inflammatory signs, but she still had a presence of a nodule of approximately 1.5 cm at the angle of the mandible.The reporter believed that the case was compatible with product accumulation.Outcome at the time of the report: nodule/cystic/suppurative nodule was not recovered/no resolved/ongoing.Grade 4 acne was unknown.Infected was unknown.Inflammatory was recovered/resolved.Purulent secretion was unknown.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 17-aug-2021 by a physician which refers to a 55-year-old female patient.Additional information was received on 20-aug-2021 and 24-aug-2021 from same reporter.The patient was not pregnant and breastfeeding.No information about medical history, concomitant medications or history of allergies has been provided.The patient had previously received treatment with sculptra in 2020 (one year ago).At that time, the patient experienced nodules in the pre ear region that improved six months after.On an unknown date in jul-2021 (45 days ago), the patient received treatment with 10 ml sculptra (lot 1j0996) to the lower third of face using an unspecified needle and cannula with unknown injection technique.The sculptra which was diluted at the time of injection.Approximately 30 days later, on an unknown date in (b)(6) 2021, the patient experienced inflammatory (implant site inflammation), nodule/cystic/suppurative nodule (implant site nodule), an infected (implant site infection) nodule near the mandible angle, which drained a much of pus/purulent secretion (purulent discharge).The patient experienced events in the left mandible region.On an unknown date in (b)(6) 2021, the patient underwent a medical appointment and as a corrective treatment the physician performed a drainage and prescribed azithromycin [azithromycin].The patient returned after two days and received a new drainage.Azithromycin was used for 7 days, without improvement.On (b)(6) 2021, the patient returned to a medical appointment and another drainage was performed.The physician informed that she was experiencing grade 4 acne (acne cystic), similar to a cystic/suppurative nodule with drainage of a lot of purulent secretion.On an unknown date in (b)(6) 2021, an unspecified gram culture was collected and sent to a lab and the result was negative.The patient was also prescribed with cephadroxil [cefadroxil] was.Currently, the patient was using cephadroxil and at the time of report she was in the 7 day of treatment.As a corrective treatment, the patient received antibiotic and systemic corticosteroids, evolving with local drainage.At the time of the report, the patient was without inflammatory signs, but she still had a presence of a nodule of approximately 1.5 cm at the angle of the mandible.The reporter believed that the case was compatible with product accumulation.As of (b)(6) 2021, the reporting physician confirmed that events were not resolved yet.Also reported that she was draining the patient for some time (time not specified).Outcome at the time of the report: nodule/cystic/suppurative nodule was not recovered/no resolved/ongoing.Grade 4 acne was not recovered/no resolved/ongoing.Infected was not recovered/no resolved/ongoing.Inflammatory was not recovered/no resolved/ongoing.Purulent secretion was not recovered/no resolved/ongoing.Tracking list: v.0 initial v.1 fu received on 15-sep-2021 from the same reporter.Outcome of events updated.

Manufacturer Narrative

Company comment: the serious events of nodule, infection at implant site and acne cystic and the non-serious events of inflammation at implant site and purulent discharge were considered expected and possibly related to the treatment.Serious criteria include the need for multiple medical and surgical interventions to prevent permanent damage.Potential root cause include injection procedure associated with inadequate aseptic technique.The case meets the criteria for expedited reporting to the regulatory authorities.Product note:routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was not a valid lot number for a galderma product.A follow up will be performed to obtain the lot number.The currently performed routine investigations are considered adequate but a batch record review will be requested if provided in order to rule out a non-conforming product.

• 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
• MDR Report Key: 12482828
• MDR Text Key: 271776481
• Report Number: 9710154-2021-00058
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P030050S002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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: 01/31/2024
• Device Lot Number: 1J0996
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 60