Catalog Number 689310 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Swelling (2091); Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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This report is for the second patient.The device is available for evaluation, though results are not available 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 eight students experienced an allergic reaction after using jeltrate alginate impression materials.No medical intervention was required.The symptoms reported include mouth sores in each student.
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Manufacturer Narrative
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The returned device failed set time, compressive strength and flow testing.Retain product was tested and found to be within specification.A dhr review was conducted with no discrepancies noted.Root cause unknown.
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Search Alerts/Recalls
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