Catalog Number 195-160 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Red Eye(s) (2038); Burning Sensation (2146)
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Event Date 11/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Technical service provided the safety data sheet and advised the consumer to contact their health provider if any irritation occurred.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) 2023.Per the consumer, he accidentally added the reagent solution in each eye as his eye drop.The consumer experienced burning eyes and red eyes.The consumer was advised to flush his eyes with water and seek medical attention if any burning or itching occurred.
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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.The reported issue of reagent exposure 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) 2023.Per the consumer, he accidentally added the reagent solution in each eye as his eye drop.The consumer experienced burning eyes and red eyes.The consumer was advised to flush his eyes with water and seek medical attention if any burning or itching occurred.
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Search Alerts/Recalls
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