Catalog Number 195-160 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Fda udi - (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.
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Event Description
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The consumer reported accidental reagent exposure to her eye with a binaxnow covid-19 antigen self-test on (b)(6) 2024.Per the consumer, the reagent solution splashed on her one eye.No additional information was provided.
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Manufacturer Narrative
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Fda udi - (b)(6) a product deficiency was not reported or found.Technical service provided the safety data sheet and advised the consumer to contact their health provider if any irritation occurred.A supplemental report will be provided if any additional information is obtained.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.H3 other text : single use; device discarded.
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Event Description
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The consumer reported accidental reagent exposure to her eye with a binaxnow covid-19 antigen self-test on (b)(6)2024.Per the consumer, the reagent solution splashed on her one eye.The consumer washed her eye immediately and confirmed she was not having any irritation or burning sensation.Consumer did not require any further medical intervention and there was no reported patient impact.The consumer confirmed there was no death or serious injury.No additional information was provided.
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Manufacturer Narrative
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Fda udi - (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H6 - health effect - impact code h3 other text : single use; device discarded.
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Event Description
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The consumer reported accidental reagent exposure to her eye with a binaxnow covid-19 antigen self-test on (b)(6) 2024.Per the consumer, the reagent solution splashed on her one eye.The consumer washed her eye immediately and confirmed she was not having any irritation or burning sensation.Consumer did not require any further medical intervention and there was no reported patient impact.The consumer confirmed there was no death or serious injury.No additional information was provided.
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Search Alerts/Recalls
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