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

Lot Number 1J3401

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

Patient Problems Bacterial Infection (1735); Hematoma (1884); Inflammation (1932); Necrosis (1971); Scar Tissue (2060); Ulcer (2274); Blister (4537); Implant Pain (4561); Reaction to Medicinal Component of Device (4574); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious expected events of ulcer, necrosis at implant site and dermatitis bullous, and the non-serious expected events of pain, induration and haematoma at implant site, scab at injection site, and the unexpected event of panniculitis were considered possibly related to the treatment.Potential root cause include the treatment procedure.The serious event of aeromonas infection was considered unexpected and unrelated to the treatment.Alternative etiology include exposure to marine water at beach.This could also be a contributory factor to the related events.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The sculptra was intentionally misused (higher reconstitution volume).The case meets the criteria for expedited reporting to the regulatory authorities.Product note: found on product page of case at icon.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 valid and verified the reported product.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.No corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Recommendation for corrective and preventative action: sculptra-no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 07-mar-2022 by a physician which refers to 58-year-old white female patient.No information about medical history, history of allergies or previous filler treatments has been provided.Concomitant medications included aas [acetylsalicylic acid], cicaplast [copper gluconate, hyaluronate sodium, madecassoside, manganese gluconate, zinc gluconate] for massage and somalgin cardio [magnesium carbonate, aluminum glycinate, acetylsalicylic acid], 1 tablet a day, from (b)(6) 2022 (3 weeks before the procedure) to (b)(6) 2022 (stopped the day after the procedure).On (b)(6) 2022, the patient received treatment with 2 vials (40 ml) sculptra (lot 1j3401), 1 vial per side to the region above the knees.Each vial of sculptra was diluted to 20 ml, giving a total dose of 40 ml.The injection was described as performing anesthetic buttons with lidocaine [lidocaine] with vasoconstrictor, performing orifices and application in fan using a 22g cannula.The each vial of sculptra was diluted to 20 ml, giving a total dose of 40 ml (intentional device misuse).At the end of the sculptra injection, the patient experienced a large hematoma (implant site haematoma) on each knee.The reporter prescribed hirudoid [mucopolysaccharide polysulfate] to the patient as corrective treatment.On (b)(6) 2022, the patient contacted the reporting physician complaining of local pain/stinging (implant site pain) and bullous lesions/ blisters (dermatitis bullous).At the clinic, the bullous lesions at the hematoma sites were noticed.The patient received application with red led for 15 min and an injection with hyaluronidase [hyaluronidase] as corrective treatment.The patient left the clinic with empty bullous lesions and a prescription of diprogent cream [betamethasone dipropionate, gentamicin sulfate] to use twice per day.On (b)(6) 2022, the patient still had 3 bullous lesions.The physician performed perforations in the roof of the blister and requested the patient to perform 7 cycles of yellow led and use unspecified corticoid.According to the physician, there was no signs of local infection.On (b)(6) 2022, the patient had three ulcerated lesions (implant site ulcer) with an area of central necrosis (implant site necrosis).The physician prescribed meticorten [prednisone] 20 mg for 3 days.The patient also experienced a hardened area (implant site induration) around one lesion, which was treated with double yellow led.On (b)(6) 2022, the patient experienced improvement in lesions but there was still central crust (injection site scab) with smaller diameter.On (b)(6) 2022, the patient experienced an ulcerated and dry lesion with a central crust.The physician prescribed nph insulin [insulin isophane bovine] and kollagenase [collagenase] as corrective treatment.On (b)(6) 2022, the patient contacted the reporting physician and reported stinging and local pain.The physician prescribed keflex [cefalexin monohydrated] 1 gram every 6 hours for 7 days and meticorten [prednisone] 40 mg per day.The physician also requested the patient to undergo blood examinations.On (b)(6) 2022, the patient continued to experience events but there was a slow improvement of lesions and local symptoms.In (b)(6) 2022, the patient was referred to another physician to perform ultrasound in the affected area, to rule out the hypothesis of pyoderma gangrenosum.There was no deep involvement, only hypervascularization in the dermis and mild panniculitis (panniculitis) was seen on the ultrasound.In addition, the patient underwent a biopsy, where the sample was collected from the center and edge of the lesion, and fragments were sent for histopathology analysis and cultures of fungi, bacteria, and mycobacteria.The biopsy site was very friable.The patient continued the treatment with steroids and antibiotics.On (b)(6) 2022, the culture analysis results confirmed growth of aeromonas caviae, anaerobic bacteria (aeromonas infection) from a marine environment.The patient informed that she went to the beach on (b)(6) 2022 (the day after the sculptra application).The patient was thereafter referred to an infectious disease specialist.On an unknown date, the patient had underwent some laboratory tests with normal results for blood test and ultrasound.The computed tomography did not show deep tissue involvement, only an ulcerated lesion was shown.On (b)(6) 2022, the patient was started on specific antibiotic therapy.On (b)(6) 2022, the patient had two closed lesions and one lesion remained ulcerated.Until (b)(6) 2022, the patient was still evolving for clinical improvement but still had an ulcerated lesion.The patient was not hospitalized due to the adverse events.The reporter assessed the events as severe.The reporter assessed the causality as contamination by an exclusive marine environment bacterium - aeromonas caviae as the patient went to the beach the day after the sculptra treatment.Outcome at the time of the report: bullous lesions/blisters was recovering/resolving.Ulcerated lesions was recovering/resolving.Central necrosis was recovering/resolving.Aeromonas caviae, anaerobic bacteria was recovering/resolving.Large hematoma was recovering/resolving.Local pain/stinging was recovering/resolving.Hardened area was recovering/resolving.Central crust was recovering/resolving.Panniculitis was recovering/resolving.Each vial of sculptra was diluted to 20 ml, giving a total dose of 40 ml was recovered/resolved.Tracking list: v.0 initial.V.1 fu received on 04-apr-2022 from the same reporter: events (implant site ulcer, necrosis, haematoma, pain, induration,, injection site scab, panniculitis, aeromonas infection, dermatitis bullous and intentional device misuse) added.Patient demographics, concomitant medications, suspect device implant date, location, volume, needle type, injection technique, lot number, corrective treatments and laboratory test details were added.Case upgraded to serious.

• Brand Name: SCULPTRA
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 14104416
• MDR Text Key: 294529427
• Report Number: 9710154-2022-00025
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P030050/S034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 1J3401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• 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
• Treatment: AAS-ACETYLSALICYLIC ACID; CICAPLAST FOR MASSAGE; SOMALGIN CARDIO-1 TABLET DAILY FOR 3 WEEKS PRIOR
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Race: White