Catalog Number 195-000 |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Red Eye(s) (2038); Eye Pain (4467)
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Event Date 12/06/2022 |
Event Type
Injury
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Event Description
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The customer reported a few drops of reagent solution landed in her eye with the binaxnow covid-19 ag self test on (b)(6) 2022.The customer reported that as a result of being exposed to the reagent, she experienced a red eye and burning sensation.Technical services informed the customer that she needs to wash her eye under running water and sent the customer the safety data sheet for binaxnow¿ covid-19 antigen self-test otc reagent via email.No additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Device not returned, single use.
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Event Description
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The customer reported a few drops of reagent solution landed in her eye with the binaxnow covid-19 ag self test on (b)(6) 2022.The customer reported that as a result of being exposed to the reagent, she experienced a red eye and burning sensation.Technical services informed the customer that she needs to wash her eye under running water and sent the customer the safety data sheet for binaxnow¿ covid-19 antigen self-test otc reagent via email.No additional patient 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.
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Search Alerts/Recalls
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