Catalog Number 195-160 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
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Event Date 09/11/2023 |
Event Type
malfunction
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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.H3 other text: single-use: device discarded.
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Event Description
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The consumer¿s nurse reported an accidental reagent exposure to the nostrils with a binaxnow covid-19 antigen self-test on (b)(6) 2023.The consumer dipped the test swab in the reagent first then swabbed their nose.The consumer experienced burning and inflammation as a result of the exposure.The nurse flushed the consumer¿s nose with water until no longer inflamed.Consumer stated she was fine after the exposure and did not require any further medical intervention.No additional information was provided.
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Event Description
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The consumer¿s nurse reported an accidental reagent exposure to the nostrils with a binaxnow covid-19 antigen self-test on (b)(6) 2023.The consumer dipped the test swab in the reagent first then swabbed their nose.The consumer experienced burning and inflammation as a result of the exposure.The nurse flushed the consumer¿s nose with water until no longer inflamed.Consumer stated she was fine after the exposure and did not require any further medical intervention.No additional information was provided.
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Manufacturer Narrative
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A product deficiency was not reported or found.Technical services was unable to send the customer the reagent safety data sheet as the customer declined to provide any other patient information.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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Search Alerts/Recalls
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