(b)(4).
Further information from the reporter regarding event, product, or patient details has been requested.
No additional information is available at this time.
The events of lumps, redness, pain, swelling, blistering, sensitive, blocked feeling, pus and vascular event are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.
A review of the device history record has been initiated.
If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
Device labeling: contra-indications: do not inject juvéderm® voluma® with lidocaine into the blood vessels (intravascular).
Intravascular injection may lead to embolisation, occlusion of the vessels, ischaemia or infarction.
Undesirable effects" the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed.
These include but are not limited to: inflammatory reactions (redness, oedema, erythema, etc.
) which may be associated with itching and/or pain on pressure and/or paraesthesia, occurring after the injection.
These reactions may last for a week.
Induration or nodules at the injection site.
Rare but serious adverse events associated with intravascular injection of dermal fillers in the face and tissue compression have been reported and include temporary or permanent vision impairment, blindness, cerebral ischaemia or cerebral haemorrhage, leading to stroke, skin necrosis and damage to underlying structures.
Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in the vision, signs of stroke, blanching of the skin or unusual pain during or shortly after the procedure.
Patients should receive prompt medical attention and possibly evaluation by an appropriate medical practitioner specialist should an intravascular injection occur.
Abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have also been reported.
It is therefore advisable to take these potential risks into account.
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Healthcare professional reported injecting a patient with juvéderm ultra plus xc in the nasolabial folds and lips.
A 25g cannula was used to inject the product, but during the injection on the 2nd side (left): the cannula started leaking.
An attempt was made to screw the cannula on tighter, but the cannula would not properly lock onto the syringe and the rest of the procedure was done with the packaged needle.
About 6 hours after the injection, the patient developed redness, pain, swelling and blistering in the left cheek.
Patient also mentioned having the inside of their left nostril feel sensitive and blocked soon after the injections.
There was also small lumps and redness forming towards the eye after the injection.
It was 3 days after the injection the healthcare professional would be notified of these symptoms.
Patient reviewed was reviewed and it was noted that redness and pus had formed.
Patient had developed a vascular occlusion on the left side.
Patient was treated with hylase on a daily basis as well as platelet rich plasma treatment.
Patient was reviewed again a week later and he redness had improved and no necrosis of the skin was seen.
The blisters, pain and swelling had subsided.
Symptoms had been improving daily.
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