Catalog Number 1001-0622 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994)
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Event Date 05/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of medwatch report mw5109755 was noted to be (b)(4) 2022.Consumer provided the lot number of the inteliswab test kit (21036-01x) and expiration date is 03/22/2022.Consumer did not provide date they used the inteliswab tests.
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Event Description
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Oti received medwatch report mw5109755, via email from the fda.Consumer voluntarily submitted the mdr for inteliswab.Consumer stated after using inteliswab they started having sinus, headache, bloody nose and ear pain.Consumer stated the symptoms would last the remainder of test day, the following day and on the third day only a little remainder of blood remained in the nose.Consumer stated they used the test exactly as described in the instructions except the consumer was only required to use one swab in the kit per week as long as they tested negative.Consumer took a total of 5 tests.As the covid levels went down in the community, the consumer stopped testing.
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Manufacturer Narrative
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5/20/22-date of medwatch report mw5109755 was noted to be 5/14/2022.Consumer provided the lot number of the inteliswab test kit (21036-01x) and expiration date is 03/22/2022.Consumer did not provide date they used the inteliswab tests.6/6/2022- oti emailed consumer on 5/31/2022 to gather more information about the event.The consumer stated they used the inteliswab test prior to expiry.The consumer stated that they went to the (b)(6) hospital emergency room on (b)(6) 2022 to report symptoms of headache, burning in nose and ear pain.Consumer received a dr.Note to abstain from testing with a nasal swab and to request an alternate saliva test.The consumer stated they performed the test using the instructions on the package insert.Currently oti is evaluating changing the inteliswab ifu to reduce risk of future events.At this time, no further information is expected by this consumer in order to continue an investigation.This complaint file will be closed internally.
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Event Description
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Oti received medwatch report mw5109755, via email from the fda.Consumer voluntarily submitted the mdr for inteliswab.Consumer stated after using inteliswab they started having sinus, headache, bloody nose and ear pain.Consumer stated the symptoms would last the remainder of test day, the following day and on the third day only a little remainder of blood remained in the nose.Consumer stated they used the test exactly as described in the instructions except the consumer was only required to use one swab in the kit per week as long as they tested negative.Consumer took a total of 5 tests.As the covid levels went down in the community, the consumer stopped testing.
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Search Alerts/Recalls
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