Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Hematoma (1884); Inflammation (1932); Swelling (2091)
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Event Date 07/19/2016 |
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 dentist used carbocaine and septocaine, which are not part of our recommended local anesthetics.The event is possibly related to the product.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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Doctor reported that a patient had swelling on the same night of dental treatment and bruising the next day.Patient also had other symptoms that were unrelated.During treatment one cartridge of carbocaine and 1 cartridge of septocaine was administered.The bruising resolved in 10 days.The patient visited another doctor because she had inflammation in the nasal cavity and was not sure if it was related to the dental injection or if it was medically related.Patient was placed on antibiotics and recovered.
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Manufacturer Narrative
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The doctor's office also reported that patient had a hematoma.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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