Catalog Number 195-160 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Red Eye(s) (2038)
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Event Date 09/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D4 udi: (b)(4).The investigation remains in progress.A supplemental report will be provided after completion.Abbot technical services emailed a copy of the safety data sheet to the consumer for their records.H3 other text : single use; device discarded.
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Event Description
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The consumer reported adding reagent drops from the binaxnow covid-19 antigen self-test to their eyes on (b)(6) 2023 after mistaking it for their non-prescription eye drop bottle.The consumer reported having redness on their left eye after washing with water.The consumer confirmed there was no harm caused by the accidental exposure to the reagent.No additional information was reported.
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Manufacturer Narrative
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D4 udi: (b)(4).A product deficiency was not reported or found.Technical service provided the safety data sheet to the customer.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 adding reagent drops from the binaxnow covid-19 antigen self-test to their eyes on (b)(6)2023 after mistaking it for their non-prescription eye drop bottle.The consumer reported having redness on their left eye after washing with water.The consumer confirmed there was no harm caused by the accidental exposure to the reagent.No additional information was reported.
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Search Alerts/Recalls
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