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

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Hematoma (1884); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/14/2021

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious events of implant site abscess and mycobacterial infection and the non-serious events of inflammation and haematoma at implant site, and acne were considered expected and possibly related to the treatment.Serious criteria include the need for 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.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the currently performed investigations.Manufacturer narrative: 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 9j2568000 was not a valid lot number for a galderma product, however, the lot number 9j2568 is a valid lot number for a galderma product.A follow up will be performed to clarify the reported lot number.When the lot number is confirmed a batch record review will be requested.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 dentist which refers to a (b)(6) white female patient.Additional information was received on (b)(6) 2021 from the same reporter.The patient's medical history included rhinoplasty, cesarean section and closure of interventricular communication without additional comorbidities.The patient had previously received treatment with sculptra (unknown amount, lot number, injection technique and needle type), on an unknown date, at an unknown location, for an unknown indication.The product was diluted 24h before the procedure with water for injection.The patient did not used any concomitant medication before or after sculptra.The reporter informed that the patient had already received two sculptra injection and the patient did not experience any problem.On (b)(6) 2021, the patient received treatment with 10 ml sculptra (invalid lot 9j2568000 reported, could be a discrepancy as lot 9j2568 is valid), 5 ml in each hemiface, by subcutaneous detachment with posterior application of the product with cannula 22g x 50 mm at malar region and facial vestibule (unknown injection technique), for an unknown indication.The product was diluted 24h before the procedure with water for injection [water for injection].8 days later, on (b)(6) 2021, the patient experienced appearance of a something like a pimple(acne) and unspecified medication was used as a corrective treatment.20 days later, on (b)(6) 2021, the patient experienced a nodule/large wound/cyst/abscess(implant site abscess) at the external vestibule, 2 cm from the angle of the mouth.On an unknown date in 2021, the nodule evolved and suffered rupture and the patient also developed a hematoma(implant site haematoma) that was drained extraoral.The patient underwent a medical appointment 15 days after start of the events with a dermatologist, plastic surgeon and with an infectiologist, who prescribed antibiotics and conservative clinical advice, but without the full resolution of the case.As a corrective treatment, two intraoral drainages were performed on an unknown date, and after it an extraoral drainage was also performed (unknown date).The patient received clavulin bd [amoxicillin trihydrate, clavulanate potassium], intramuscular rocefin [ceftriaxone sodium] and oral dalacin [clindamycin hydrochloride], since an unknown date in (b)(6) 2021.The patient was not hospitalized.On an unknown date in 2021, the patient also underwent some lab tests such as ultrasound, tomography, magnetic resonance and the image tests suggested liquid collection with a wrapper suggesting cyst/abscess.Also, a hematologic test was performed without significant alteration.Events severity was assessed as severe by the reporter.On an unknown date in 2021, after 45 days, the patient experienced the peak of the injury, with floating point of contamination.On an unknown date in 2021, as a corrective treatment, two intraoral drainages were performed and after it an extraoral drainage was also performed.At that time, the reported collected material for culture and the result was presence of mycobacteria acid-alcohol resistant bacillus (baar) 3+.The patient had mycobacterium infection(mycobacterial infection).After the last drainage, the patient experienced a good regression of the injury.On an unknown date in 2021, at the injection site, the patient experienced inflammatory hypoxia(implant site inflammation) that almost evolved into necrosis but was managed to intervene.The reporter does not know the cause of the contamination because, according to him, he followed the correct protocols of decontamination and care.At the time of this report, the patient was receiving an unspecified medication for 4 days ago.Outcome at the time of the report: nodule/large wound/cyst/abscess was not recovered/not resolved.Mycobacterium infection was unknown.Hematoma was not recovered/not resolved.Pimple was unknown.Inflammatory hypoxia was unknown.Tracking list: v.0 initial v.1 fu received on (b)(6) 2021 from same reporter.Case upgraded to serious due to required intervention to prevent permanent damage.Events (inflammation at implant site, mycobacterial infection and pimple) added.Verbatim of implant site abscess updated.

• 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
• 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: 11809183
• MDR Text Key: 261731596
• Report Number: 9710154-2021-00030
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P030050S002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/11/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/11/2021
• 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
• Patient Age: 49 YR
• Patient Weight: 59