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

Lot Number 1J3671

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

Patient Problems Hyperemia (1904); Hypersensitivity/Allergic reaction (1907); Red Eye(s) (2038); Sore Throat (2396); Numbness (2415); Unspecified Ear or Labyrinth Problem (4474); Dry Mouth (4485); Skin Disorders (4543); Alteration in Body Temperature (4568); Peripheral Edema (4578)

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious expected event of hypersensitivity, and the non-serious expected events of hypoaesthesia, feeling hot, papule and the unexpected events of dry mouth, ear discomfort, peripheral swelling, oropharyngeal discomfort, hyperaemia and conjunctival hyperaemia were considered possibly related to the treatment.Serious criteria included the need for urgent medical care including medical interventions to prevent a life-threatening condition and permanent damage.The likely root cause include the patient's hypersensitivity to the product.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: sculptra-routine investigations have been performed and indicate a possible involvement of the product.Lot number was not reported and the product could not be verified.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.Recommendation for corrective and preventive 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 (b)(6) 2022 by a physician via sales representative which refers to a female patient of an unknown age.No information about medical history, concomitant medication, history of allergies or previous filler treatments had been provided.On an unknown date, the patient received treatment with sculptra to an unknown location (unknown amount, lot number, injection technique and needle type).Minutes after the sculptra treatment and after usual massage at the injection site, the patient experienced an allergic reaction (hypersensitivity).The reporter described the allergic reaction as feeling hot (feeling hot) and burning sensation in the ears (ear discomfort), followed by numbness (hypoaesthesia) in the lips, around the mouth, and roof of the mouth.The patient also experienced throat discomfort (oropharyngeal discomfort) and dry mouth (dry mouth).From that, the patient became hyperemic (nos) (hyperaemia) including experienced conjunctival hyperemia (conjunctival hyperaemia), and also experienced papules (papule) throughout the body (starting in the upper limbs, spreading to trunk, lower limbs and feet).According to the reporter, the last clinical manifestation was swelling of hands and less intense on the feet (peripheral swelling).The patient was treated in the emergency room with hydrocortisone [hydrocortisone] 300 mg intravenously, adrenaline injection [epinephrine bitartrate] intramuscularly, fenergan [promethazine hydrochloride] intramuscularly and allegra [fexofenadine hydrochloride] via oral route.Outcome at the time of the report: allergic reaction was unknown.Feeling hot was unknown.Burning sensation in the ears was unknown.Numbness was unknown.Throat discomfort was unknown.Dry mouth was unknown.Hyperemic (nos) was unknown.Conjunctival hyperemia was unknown.Papules was unknown.Swelling of hands and less intense on the feet was unknown.

Manufacturer Narrative

Company comment: the serious expected event of hypersensitivity, and the non-serious expected events of hypoaesthesia, feeling hot, papule and the unexpected events of dry mouth, ear discomfort, odema peripheral, oropharyngeal discomfort, hyperaemia and conjunctival hyperaemia were considered possibly related to the treatment.Serious criteria included the need for urgent medical care including medical interventions to prevent a life-threatening condition and permanent damage.The likely root cause include the patient's hypersensitivity to the product.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: 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.Batch record review has been performed.Sanofi confirms that no quality issues have been identified in the overall manufacturing process of the specified batch.The batch released is conforming with the cgmp and to the specification requirements.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventive 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 (b)(6) 2022 by a physician via sales representative which refers to a 57-year-old white female patient.The patient's medical history included bronchitis in childhood.No information about history of allergies or previous filler treatments had been provided.On (b)(6) 2022, the product sculptra was reconstituted in 8ml of distilled water [distilled water] and kept at a temperature below 25°c.On (b)(6) 2022, the 2ml of lidocaine [lidocaine] without adrenaline was added to reconstituted sculptra and syringes were prepared for injection.On (b)(6) 2022, the patient received treatment with 5 ml sculptra (lot 1j3671) to fat pads regions (1 ml in lower temporal, 1.5 ml in upper temporal, 2 ml in lateral malar fat pad) and 3 points in supraperiosteal malar region (total dose of 0.5ml) using cannula 22g/ 50 mm with unknown injection technique to each side of the face, posterior to the line of ligaments.On (b)(6) 2022, minutes after the sculptra treatment and after usual massage at the injection site, the patient experienced an allergic reaction (hypersensitivity).The reporter described the allergic reaction as feeling hot (feeling hot) and burning sensation in the ears (ear discomfort), followed by numbness (hypoaesthesia) in the lips, around the mouth, and roof of the mouth.The patient also experienced throat discomfort (oropharyngeal discomfort) and dry mouth (dry mouth).From that, the patient became hyperemic (nos) (hyperaemia) including conjunctival hyperemia (conjunctival hyperaemia), and also experienced papules (papule) throughout the body (starting in the upper limbs, spreading to trunk, lower limbs and feet) and hands edema and feet edema (odema peripheral) (less intense than hand edema).On (b)(6) 2022, 11:30 am, the patient was taken to the emergence room and received urgent treatment medications of adrenaline [epinephrine bitartrate] at a dose of 0.2 ml intramuscularly, hydrocortisone [hydrocortisone] at a dose of 300mg intravenously, fenergan [promethazine hydrochloride] at a dose of 1 ampoule intramuscularly and allegra [fexofenadine hydrochloride] 180mg 1 tablet via oral route.At the hospital, the patient had her vital signs monitored and she was discharged from hospital on (b)(6) 2022 at 02:45 pm.The patient also received treatment with prednisolone [prednisolone] at a dose of 20mg daily for 3 consecutive days.3 hours after the specific medication administered, almost all adverse events disappeared, only hands edema lasted until (b)(6) 2022.The hands edema completely disappeared on (b)(6) 2022 and since then the patient had no more complaints or manifestations of any adverse event.The patient performed the recommended massage and maintained a stable clinical condition without new complications.The reporter would no longer inject sculptra into the patient, as she believed that the condition was allergic.The reporter assessed the severity of the adverse events from moderate to serious and associated the causality as possible related to the suspect product.Outcome at the time of the report: allergic reaction was recovered/resolved.Feeling hot was recovered/resolved.Burning sensation in the ears was recovered/resolved.Numbness was recovered/resolved.Throat discomfort was recovered/resolved.Dry mouth was recovered/resolved.Hyperemic (nos) was recovered/resolved.Conjunctival hyperemia was recovered/resolved.Papules was recovered/resolved.Hands edema and feet edema was recovered/resolved.Tracking list: v.0 initial.V.1 fu received on 21-mar-2022 and 22-mar-2022 from the same reporter: the verbatim and coding of oedema peripheral updated.Patient demographics, medical history, concomitant medications, suspect device implant date, volume, device location, needle type, lot number, expiry date, event onset date, severity, outcome, reporter causality and corrective treatment details were updated.

• 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: 13907417
• MDR Text Key: 290551598
• Report Number: 9710154-2022-00022
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Lot Number: 1J3671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• 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: DISTILLED WATER; LIDOCAINE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White