Catalog Number 195-160 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
Eye Pain (4467)
|
Event Date 02/10/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Technical service provided the safety data sheet (sds) via email to consumer.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Device discarded; single-use device.
|
|
Event Description
|
The consumer reported accidental exposure to the binaxnow covid-19 self-test reagent on (b)(6) 2023.Per the consumer, he accidentally splashed the reagent in his eyes.The consumer reported "washing" his eyes with water and stated that his eyes still "facing burning sensation".The consumer was advised to seek medical attention as he is still facing burning sensations.
|
|
Event Description
|
The consumer reported accidental exposure to the binaxnow covid-19 self-test reagent on (b)(6) 2023.Per the consumer, he accidentally splashed the reagent in his eyes.The consumer reported "washing" his eyes with water and stated that his eyes still "facing burning sensation".The consumer was advised to seek medical attention as he is still facing burning sensations.
|
|
Manufacturer Narrative
|
A product deficiency was not reported or found.Technical service provided the safety data sheet and advised the consumer to contact their health provider for medication as he is still facing burning sensations.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.H1: type of reportable event.H3 other text : device discarded; single-use device.
|
|
Search Alerts/Recalls
|