Catalog Number 195-160 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Burning Sensation (2146)
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Event Date 04/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Technical service provided the safety data sheet (sds) to the consumer.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.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 eye with the binaxnow covid-19 antigen self-test reagent on (b)(6) 2023.Per the patient, she mistaken the reagent as her eye dropper.She immediately called the poison organization hotline number and was advised to clean her eyes with clean water.The consumer stated that she was experiencing a burning sensation in her eye before and after washing with water as directed by poison organization.No additional information was provided.
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Event Description
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The consumer reported accidental exposure to the eye with the binaxnow covid-19 antigen self-test reagent on (b)(6) 2023.Per the patient, she mistaken the reagent as her eye dropper.She immediately called the poison organization hotline number and was advised to clean her eyes with clean water.The consumer stated that she was experiencing a burning sensation in her eye before and after washing with water as directed by poison organization.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 provided the safety data sheet and advised the consumer to contact their health provider if any irritation occurred.The reported health status 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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Search Alerts/Recalls
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