Catalog Number 606.67.281 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Caustic/Chemical Burns (2549)
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Event Type
Injury
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Manufacturer Narrative
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Therefore, because this event resulted in medical intervention, it is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event it was reported that a patient experienced a chemical burn after a dental adhesive product, prime and bond xp, inadvertently came into contact with soft tissue.The doctor prescribed a mild steroid and burn ointment to the patient.
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Manufacturer Narrative
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Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.
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Search Alerts/Recalls
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