ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE
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Catalog Number 94151EC |
Device Problems
Burst Container or Vessel (1074); Loose or Intermittent Connection (1371); Expulsion (2933)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling addresses the reported event(s) as follows: "method of use-posology ¿ remove tip cap by pulling it straight off the syringe as shown in fig.1.Then firmly push the needle provided in the box (fig.2) into the syringe, screwing it gently clockwise.Twist once more until it is fully locked and has the needle cap in the position shown in fig.3.If the needle cap is positioned as shown in fig.4, it is incorrectly attached.Next, remove the protective cap by holding the body of the syringe in one hand, the protective cap in the other, as shown in fig.5, and pulling the two hands in opposite directions.Prior to injecting, depress the plunger rod until the product flows out of the needle.Inject slowly and apply the least amount of pressure necessary.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level and/or increase the risk of vascular compromise.".
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Event Description
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Healthcare professional reported during injection with 1 syringe of juvéderm® voluma¿ with lidocaine into the left malar area, they ¿put the cannula 25g through the hole¿ and started the compression of the plunger.Healthcare professional reported that ¿suddenly, the thread of the syringe collapsed (bursting noise), the cannula fitting loosened and almost all material was lost around the syringe and no product was injected.¿ according to the healthcare professional, there was a possible ¿failure of the syringe thread.¿ no injuries occurred to the patient, injector, or staff.A juvéderm® voluma¿ with lidocaine syringe from the same box was used on the patient¿s right side with no intercurrences.
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Manufacturer Narrative
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Device analysis: two empty syringes of 1.0 ml each received with caps, no needles.No defect observed to both syringes.
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Event Description
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Healthcare professional reported during injection with 1 syringe of juvéderm® voluma¿ with lidocaine into the left malar area, they ¿put the cannula 25g through the hole¿ and started the compression of the plunger.Healthcare professional reported that ¿suddenly, the thread of the syringe collapsed (bursting noise), the cannula fitting loosened and almost all material was lost around the syringe and no product was injected.¿ according to the healthcare professional, there was a possible ¿failure of the syringe thread.¿ no injuries occurred to the patient, injector, or staff.A juvéderm® voluma¿ with lidocaine syringe from the same box was used on the patient¿s right side with no intercurrences.
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Search Alerts/Recalls
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