Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Hematoma (1884); Swelling (2091)
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Event Date 04/12/2016 |
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 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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A dentist reported a patient had swelling and severe bruising on the same night as his dental treatment.The swelling did not resolve and the patient visited a physician in a different office who prescribed antibiotics, possibly amoxicillin.The patient's mother followed up with the dental office and confirmed her son was 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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