DENTSPLY PROFESSIONAL NUPRO EXTRA CARE PROPHY PASTE, SPEARMINT POLISH WITH FLUORIDE; AGENT, POLISHING, ABRASIVE, ORAL CAVITY
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Catalog Number 801600 |
Device Problems
Patient-Device Incompatibility (2682); Insufficient Information (3190)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Complaint, Ill-Defined (2331); Sore Throat (2396); Reaction (2414)
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Event Date 05/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.This report is for the first patient.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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It was reported that two patient's experienced an allergic reaction following treatment with nupro extra care polish spearmint.In the first patient, they reported a sore throat and that their cheeks were feeling like they were stuck to their teeth.No medical treatment was needed.The symptoms were still present several weeks after treatment.
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Manufacturer Narrative
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Multiple unsuccessful attempts were made to obtain the device for evaluation.Retain product was tested and found to be within specification.Also, a dhr review was conducted with no discrepancies noted.
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Search Alerts/Recalls
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