Catalog Number 195-160 |
Device Problems
Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
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Patient Problem
Red Eye(s) (2038)
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Event Date 12/21/2023 |
Event Type
malfunction
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Event Description
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The consumer reported an accidental reagent exposure to the eyes with a binaxnow covid-19 antigen self-test on (b)(6).2023.Per the consumer, she accidently put reagent into her eyes as she was opening the bottle of the reagent.The consumer had mistakenly used the reagent solution as her eye drops.Consumer stated her eyes became red after flushing with water.Consumer also stated she was not having any irritation and was fine after the exposure and did not require any further medical intervention.There was no reported patient impact.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.H3 other text : single use; device discarded.
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Manufacturer Narrative
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Fda udi ¿ (b)(4).A product deficiency was not reported or found.Technical service provided the safety data sheet.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 an accidental reagent exposure to the eyes with a binaxnow covid-19 antigen self-test on (b)(6) 2023.The consumer mistakenly used the reagent solution as her eye drops.Consumer stated her eyes became red after flushing with water.Consumer also stated she was not having any irritation and was fine after the exposure and did not require any further medical intervention.There was no reported patient impact.No additional information was provided.
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Event Description
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The consumer reported an accidental reagent exposure to the eyes with a binaxnow covid-19 antigen self-test on (b)(6) 2023.The consumer mistakenly used the reagent solution as her eye drops.Consumer stated her eyes became red after flushing with water.Consumer also stated she was not having any irritation and was fine after the exposure and did not require any further medical intervention.There was no reported patient impact.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.B5 h-6: medical device problem code h3 other text : single use; device discarded.
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Search Alerts/Recalls
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