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

Lot Number 0J9206

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

Patient Problems Granuloma (1876); Viral Infection (2248); Subcutaneous Nodule (4548); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious events of mass at implant site and granuloma skin and the non-serious events of oedema at implant site and needle track marks were considered expected and possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The potential root cause is the treatment procedure.Potential contributory factor for oedema at implant site include corrective treatment with lymph and triad injections.Intentional device misuse was reported as sculptra was incorrectly reconstituted.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: sculptra-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.Until 15-jun-2021, no events had been reported on the lot.A repeated batch record review will be performed to rule out a non-conforming product.Capa comment: no corrective or preventive actions are deemed necessary based on the outcome of the currently performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2022 by a consumer or other non health professional concerning a (b)(6) female patient.Additional information was received from the patient herself on (b)(6) 2022 and by a cosmetologist on (b)(6) 2022.The patient's skin type included fitzpatrick i-ii and no other medical history was reported.The patient had no allergy history and was not taking any concomitant medications.The patient had previously received treatment with sculptra to face on (b)(6) 2020.On (b)(6) 2021, the patient received treatment with 2 vials sculptra (lot 0j9206) to face and neck, subdermally using 22g cannula (unknown injection technique) due to lack of volume of soft tissues of the face and flabbiness of the neck.The first vial of sculptra was reconstituted with 8 ml of water for injection [water for injection] and 2 ml of 2% lidocaine [lidocaine] for face areas and the second vial of sculptra was reconstituted with 18 ml of water for injection and 2 ml of 2% lidocaine for neck areas.The sculptra vial reconstituted with 18ml water for injection (intentional device misuse).On (b)(6) 2021, the patient experienced subcutaneous bumps (palpable indurations) (implant site mass) with d = 0.3 - 0.6 cm in submandibular area up to 1 cm on the injection site.There were also furrows from cannula (needle track marks).The oncologist suspected autoimmune thyroiditis due to increased antibodies levels in a blood test.On (b)(6) 2021, the oncologist prescribed auto-injection of lymph (take lymph and inject it to the problem side) [as reported] and triad injection (including hyaluronidase, collagenase and lipase) [as reported] 3 times, 1 time/week on (b)(6) 2021, (b)(6) 2021 and (b)(6) 2021.Percentage of the composition of the triad is unknown.After a week, on (b)(6) 2021, the patient experienced edema/swelling (implant site oedema) on the face and under chin and bumps started growing.The condition worsened.The physician rejected the diagnosis of autoimmune thyroiditis.On (b)(6) 2021, the patient received dexamethasone [dexamethasone] locally to bumps.From (b)(6) 2021 to (b)(6) 2021, the patient received dexamethasone intramuscularly 8 (unknown units) per injection.On (b)(6) 2021, the swelling resolved.From (b)(6) 2021 to (b)(6) 2021, the patient received dexamethasone intramuscularly 4 (unknown units) per injection.On (b)(6) 2021 and (b)(6) 2021, the patient met the endocrinologists.On (b)(6) 2021, the patient received dexamethasone locally to bumps and there was an improvement, bumps decreased.On (b)(6) 2022, the plastic surgeon diagnosed granuloma (granuloma skin) by ultrasound.However, histological granuloma was not confirmed as patient rejected to undergo biopsy analysis.The plastic surgeon prescribed 5-fluorouracil [5-fluorouracil] and diprospan [betamethasone dipropionate].After this treatment, there was an improvement for 5-7 days.At the time of the report, the patient had improved but was not fully recovered.Outcome at the time of the report: bumps (palpable indurations) was recovering/resolving.Granuloma was recovering/resolving.Edema/swelling was recovered/resolved.Furrows from cannula was recovering/resolving.1 sculptra vial reconstituted with 18ml water for injection was recovered/resolved.

Event Description

Case reference number(b)(4) is a spontaneous report sent on (b)(6) 2022 by a consumer or other non health professional concerning a 39-year-old female patient.Additional information was received from the patient herself on 10-feb-2022 and by a cosmetologist on 11-feb-2022.The patient's skin type included fitzpatrick i-ii and no other medical history was reported.The patient had no allergy history and was not taking any concomitant medications.The patient had previously received treatment with sculptra to face on (b)(6) 2020.On (b)(6) 2021, the patient received treatment with 2 vials sculptra (lot 0j9206) to face and neck, subdermally using 22g cannula (unknown injection technique) due to lack of volume of soft tissues of the face and flabbiness of the neck.The first vial of sculptra was reconstituted with 8 ml of water for injection [water for injection] and 2 ml of 2% lidocaine [lidocaine] for face areas and the second vial of sculptra was reconstituted with 18 ml of water for injection and 2 ml of 2% lidocaine for neck areas.The sculptra vial reconstituted with 18ml water for injection (intentional device misuse).On (b)(6) 2021, the patient experienced subcutaneous bumps (palpable indurations) (implant site mass) with d = 0.3 - 0.6 cm in submandibular area up to 1 cm on the injection site.There were also furrows from cannula (needle track marks).The oncologist suspected autoimmune thyroiditis due to increased antibodies levels in a blood test.On (b)(6) 2021, the oncologist prescribed auto-injection of lymph (take lymph and inject it to the problem side) [as reported] and triad injection (including hyaluronidase, collagenase and lipase) [as reported] 3 times, 1 time/week on (b)(6) 2021, (b)(6) 2021 and (b)(6) 2021.Percentage of the composition of the triad was unknown.After a week, on (b)(6) 2021, the patient experienced edema/swelling (implant site oedema) on the face and under chin and bumps started growing.The condition worsened.The physician rejected the diagnosis of autoimmune thyroiditis.On (b)(6) 2021, the patient received dexamethasone [dexamethasone] 8 mg once locally to bumps and then dexamethasone 8 mg, once/week for 3 weeks.From (b)(6) 2021 to (b)(6) 2021, the patient received dexamethasone intramuscularly 8 mg.On (b)(6) 2021, the swelling was resolved.The patient had underwent complete blood count test and results were within normal range.On (b)(6) 2021, the patient underwent aha, lgg immunoblot test and no antibodies against antinuclear antigen panel were detected.From (b)(6) 2021 to (b)(6) 2021, the patient received dexamethasone intramuscularly 4 milligram per injection.On (b)(6) 2021, the patient consulted the endocrinologist.According to the patient, there were small subcutaneous masses in the right side of the neck.The endocrinologist conducted various tests and following changes were detected: free t3 4.1 pm/l, free t4 12.54 pm/l, tsh 1.07 iu/l, anti-tg ab 29.2 iu/ml and tpo 827.9 u/ml.The patient was diagnosed with tpo antibody carrier status, euthyroidism.The endocrinologist had recommended thyroid ultrasound, examination of the neck, abdominal cavity and kidney and consultation of a rheumatologist.The tsh follow-up every 6 months, limited quantity of iodine containing food and assessment of microbiocenosis by mcmm by osipov.The patient was also advised to have sugar, bread and flour products, gluten-containing pasta, milk, yeast-containing food and alcohol and test for 25(oh) d3 in blood.The patient was treated with vitamin d3 [vitamin d3], detrimax 3000 iu once daily with food during dinner and fortedetrim 2000 iu (4000 mg) once daily.On (b)(6) 2021, the thyroid ultrasound test was performed and concluded with ultrasound signs of structural changes of thyroid.On (b)(6) 2021, the patient received dexamethasone 8 milligram locally to bumps and there was an improvement, bumps decreased.On (b)(6) 2022, the plastic surgeon diagnosed granuloma/multiple subcutaneous granulomas of the neck (granuloma skin) by ultrasound.No abnormal changes of lymph nodes were detected.However, histological granuloma was not confirmed as patient rejected to undergo biopsy analysis.The plastic surgeon prescribed 5-fluorouracil [5-fluorouracil] 1ml once and diprospan [betamethasone dipropionate] 1 ml once.After this treatment, there was an improvement after 5-7 days.The patient had improved but was not fully recovered.On an unknown date, the patient had experienced covid-19 (covid-19).Outcome at the time of the report: bumps (palpable indurations) was recovering/resolving.Granuloma/multiple subcutaneous granulomas of the neck was recovering/resolving.Edema/swelling was recovered/resolved.Furrows from cannula was recovering/resolving.Covid-19 was not recovered/not resolved/ongoing.1 sculptra vial reconstituted with 18ml water for injection was recovered/resolved.Tracking list: v.0 initial v.1 fu received on (b)(6) 2022 from patient herself: event (covid-19) added.Verbatim of event granuloma skin, corrective treatment and laboratory test details were updated.

Manufacturer Narrative

Company comment: the serious events of mass at implant site and granuloma skin and the non-serious events of oedema at implant site and needle track marks were considered expected and possibly related to the treatment.Serious criteria include the need for multiple medical interventions to prevent permanent damage.The potential root cause is the treatment procedure.Potential contributory factor for oedema at implant site include corrective treatment with lymph and triad injections the non-serious event of covid-19 was considered unexpected and unrelated to the treatment.Alternative etiology include community acquired viral infection.Intentional device misuse was reported as sculptra was incorrectly reconstituted.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: sculptra-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.Sanofi confirms that no quality issues have been identified in the overall manufacturing process of the specified batch.The batch is conforming with the cgmp and to the specification requirements.Until (b)(6) 2021, no events had been reported on the lot.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.Capa comment: no corrective or preventive actions are deemed necessary based on the outcome of the currently performed investigations.

• 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: 13563396
• MDR Text Key: 290528929
• Report Number: 9710154-2022-00009
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P030050/S034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Lot Number: 0J9206
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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: LIDOCAINE.; LIDOCAINE.; WATER FOR INJECTION.; WATER FOR INJECTION.
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female