Catalog Number 195-160 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Eye Pain (4467)
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Event Date 02/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The technical services provided the information regarding the chemical structure of reagent solution.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : device discarded; single-use device.
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Event Description
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The consumer reported accidental exposure to the binaxnow covid-19 antigen self-test reagent on (b)(6) 2024.Per the consumer, she mistakenly used the reagent as eye drops and added 1-2 drops of the reagent to their eyes.The consumer reported experiencing a burning sensation at first that went away after washing the eyes with water.The consumer confirmed that they had no effects from the reagent.No additional information was provided.
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Manufacturer Narrative
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A product deficiency was not reported or found.Technical service could not be sent the safety data sheet to the customer directly since they did not provide an email address.The customer was provided with the ingredients for the reagent and the number for poison control if they were to need it, and advised to seek medical assistance if they were to experience any irritation.The reported of reagent contact with eye is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.A supplemental report will be provided if any additional is obtained.H3 other text : device discarded; single-use device.
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Event Description
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The consumer reported accidental exposure to the binaxnow covid-19 antigen self-test reagent on (b)(6) 2024.Per the consumer, she mistakenly used the reagent as eye drops and added 1-2 drops of the reagent to their eyes.The consumer reported experiencing a burning sensation at first that went away after washing the eyes with water.The consumer confirmed that they had no effects from the reagent.No additional information was provided.
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Search Alerts/Recalls
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