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This mdr is related to 3013840437-2020-00125 and 3013840437-2020-00126, referring to the same patient.
This spontaneous report was received from a (b)(6) physician and concerns a (b)(6) year-old female patient.
She was injected with radiesse®, in the cheekbone area and the mandibular arch, 2 months prior to this report, in (b)(6) 2020.
Batch number was reported as 100127924.
A lot search in the global safety database was conducted.
Radiesse® was injected in vectors.
The patient was previously always treated with hyaluronic acid (as reported), with good results and tolerated the treatment well.
The patients past medical history included a tumor (some time prior to this report).
In 2020, after the treatment with radiesse®, the patient experienced a nodule, further described as an accumulation or a granuloma of radiesse®.
After an ultrasound the nodule turned out to be calcium hydroxylapatite.
As reported, the patient did not stop touching it since then, even though the physician recommended not to do so.
After that, the patient visited another physician who did not resolve anything and she returned to the injecting physician.
After two sessions of intra nodular injections with sodium thiosulfate and with trigon, the nodule did not resolve.
The patient was also prescribed corticoids.
The outcome of the event was reported as not resolved.
Follow-up information was received on 20-nov-2020: the case was upgraded to serious.
The event nodule / accumulation or a granuloma of radiesse was deleted and the events inflammatory component, hard lump/solid mass, product preparation issue and off label use of device were added.
The patient was injected with radiesse® into the left cheek area, with the technique of subcutaneous vectors.
Needle used for injection was a 25 g and 50 mm cannula.
As reported, radiesse® was diluted in 0.
3 ml of lidocaine 1%, at a dose of 0.
05 ml / by retrotraction technique (product preparation issue, off label use of device).
Concomitant medication was reported as none.
The patient did not take any medication for prophylaxis.
In (b)(6) 2020, one moth after the treatment with radiesse®, during a check up, it was noted, that the patient had a hard lump on the internal face of the left cheek and an inflammatory component around it.
It was not painful on palpation and approximately 1x1 cm, with a hard consistency.
The physician suspected as a diagnostic impression of granuloma secondary to radiesse® infiltration, and requested an ultrasound scan.
The report of the doppler ultrasound showed that the mass that was palpated in mobile left genian region, corresponded to a solid mass that did not capture contrast to the doppler study and that could correspond to a granuloma by the antecedent.
It measured 10.
47 mm x 11.
62 mm.
No histological examination was performed.
The physician initiated the treatment with trigon depot 40 mg intra and perilesional plus a decreasing oral corticoids regimen for 2 weeks.
In the revision, the physician injected intralesional thiosulfate na 0.
5 ml and in one week, the granuloma was halved and then the patient was injected again 0.
4 ml intralesional with little result that time.
It was reported that in the last revision, about a month and a half after having injected the trigon depot, the patient presented as a complication, lipoatrophy with hypochromy, in the area secondary to the corticoids.
The physician started treatment with lidocaine plus physiological serum 5 ml (one dose) that she continued for 4 or 8 weeks.
The patient was presenting partial granuloma reduction with lipoatrophy and hypochromia secondary to trigon depot treatment.
Due to provided information, the outcome of the event hard lump/solid mass was considered as resolving.
The outcome of the remaining events was unknown.
Follow-up information was received on 01-dec-2020: the batch record review was received and the lot number for radiesse® was confirmed as 100127924 (expiry date 02/2022).
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