Catalog Number 195100 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 07/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.A supplemental report will be provided after completion.
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Event Description
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The consumer reported sustaining a nasal injury while using the binaxnow covid-19 home test.The consumer reported an unspecified amount blood on the swab.(b)(6) reported that it was unclear if the consumer's nasal was swabbed twice.(b)(6) also, reported that it appeared the proctor stopped the session before any testing could take place so no actual testing occurred.However, an invalid result was reported.Although requested, no additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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The supplemental report is being submitted to provide additional information snd correct the pma/510k number from eua(b)(4) to eua(b)(4).Additional information: a product deficiency was not reported or identified.According to the package insert in195100 v.5.0: reagents and materials extraction reagent (1 or 2): bottle containing <1 ml of extraction reagent precautions invalid results can occur when an insufficient volume of extraction reagent is added to the test card.To ensure delivery of adequate volume, hold vial vertically, 1/2 inch above the swab well, and add drops slowly.Directions for running the binaxnow¿ covid-19 ag card home test 4.Apply fluid to top hole a.Remove dropper bottle cap.B.Hold dropper bottle straight over top hole, not at an angle.C.Put 6 drops into top hole.Do not touch card with tip.The product will continue to be monitored and tracked.
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Manufacturer Narrative
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The supplemental report is being submitted to correct the previously reported event.Corrected data: b4- initial report date of this report should be 30-jul-2021.
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Search Alerts/Recalls
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