Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Corneal Edema (1791)
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Event Type
Injury
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Manufacturer Narrative
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The product is not available for return and the lot number was not reported.An assessment of the event was completed by valeant medical personnel.The event is possibly related to the product but could also be by vasoconstriction from epinephrine in a pdl injection.Based on all information, no causal factors can be determined and no conclusion can be drawn.
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Event Description
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A dentist reported when he used the pen alongside a wand, the patient experienced tissue necrosis.It was a single tooth anesthesia pdl with wand technique.The pen was dialed to either 18 or 9 and lidocaine was used as a buffer.He states they would sometimes use dental vibes with the onset and wand.It is unknown if the patient experienced the necrosis immediately or after a couple days.There is no sign of infection.No medical intervention was necessary but the dentist states that it takes time to heal and may be up to a year before the tissues grow back.This report is for patient 5.
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Manufacturer Narrative
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The product was not returned and the lot number was not reported.The manufacturer's investigation identified no causal factors and no conclusion can be drawn.
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Search Alerts/Recalls
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