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Pharmacovigilance comments: the serious, expected events of skin granuloma and injection site cyst were considered possibly related to the treatment.
Serious criteria included the need for medical intervention to prevent permanent harm, including multiple antibiotics and systemic steroids.
The non-serious, expected event of face swelling was considered possibly related to the treatment.
Potential contributory factors for the event of granuloma and cyst include inflammation and infection from the treatment procedure.
The event of cyst is likely associated with granuloma which is labeled in the instructions for use.
The case meets the seriousness criteria for expedited reporting to the regulatory authorities.
Engineering evaluation: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.
Manufacturer narrative: lot number was not reported.
(b)(4).
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Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2018 by a physician referring to a (b)(6) female patient.
Additional information received on (b)(6) 2018 was included in this report.
The patient is a eye prosthesis user since she was five years old and has no concomitant medications.
The patient had previously received treatment with restylane perlane on (b)(6) 2013 (nasogenian sulcus), emervel volume (each side of lacrimal gut) and emervel classic (left and right nasogenian sulcus) in (b)(6) 2016.
On an unknown date the patient received her first treatment with sculptra.
Approximately on (b)(6) 2018, the patient received her second treatment with sculptra to the temples, malar, lateral and proximal fat pad area, and 0.
3 ml in the left and right piriform fossa.
The lot no.
, total amount used, injection technique and needle type were unknown.
It was reported that the treatments with sculptra were performed outside of emervel's previous injection sites and without intercurrences.
On (b)(6) 2018, the patient experienced swelling face(swelling face) and got a visible cyst(injection site cyst) (approximately 10 cm) in the contour of the injection sites.
On the same date, the patient sent photos to the physician that showed a left face enlargement.
The patient received a prescription of loratadine [loratadine] for oral use.
In (b)(6) 2018, the patient visited the physician.
At the examination the physician visualized a picture of cystic lesion, more palpable than visible with fibroelastic consistency and absence of phlogistic signs in the left nasogenian sulcus.
On (b)(6) 2018, the patient underwent an ultrasonography which showed a cystic lesion of about 5.
0 ml of content in the left nasogenian sulcus.
On (b)(6) 2018, a puncture of the lesion was performed where the contents were described as a serous yellow-dark liquid.
On an unknown date, the patient received corrective treatment with clarithromycin [clarithromycin], ciprofloxacin [ciprofloxacin] and systemic corticosteroid [corticosteroids for systemic use] in the last three days (as reported).
A cytology test of the punctured fluid was performed which showed giant cell histiocytic and neutrophil granulomatous reaction(granuloma skin).
The physician reported that the cyst was improving, because when it appeared it was visible, but currently it was only palpable.
Outcome at the time of the report: swelling face was unknown.
Cyst was recovering/resolving.
Giant cell histiocytic and neutrophil granulomatous reaction was unknown.
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