Catalog Number 195-160 |
Device Problem
Device Handling Problem (3265)
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Patient Problems
Conjunctivitis (1784); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2023 |
Event Type
malfunction
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Event Description
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Consumer reported reagent contact with eyes while performing binaxnow covid-19 ag self test on (b)(6) 2023.Consumer mistook the reagent bottle for eyes drops and put some on her eyes and she had eye irritation.No additional information, including treatment and outcome, was provided.
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Manufacturer Narrative
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The investigation is still in progress.A supplemental report will be provided after completion.Single use device, device discarded.
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Event Description
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Consumer reported reagent contact with eyes while performing binaxnow covid-19 ag self test on (b)(6) 2023.Consumer mistook the reagent bottle for eyes drops and put some on her eyes and she had eye irritation.No additional information, including treatment and outcome, was provided.
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Manufacturer Narrative
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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.H6-health effect impact code h3 other text : single use device, device discarded.
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Search Alerts/Recalls
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