Device not returned.Ccds staff has been in contact with hcp, explaining the decontamination process, the chemicals used (sdss), the potential issues with the fit and the odor, and provided a link to faqs for hcps as well as suggesting airing out the masks prior to use.Although no malfunction or serious injury of the decontaminated respirator has been confirmed, this report is required under the terms of the eua.All information known or reasonably known to battelle has been included in this submission.Any blank fields indicate that information was unavailable.
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User reported after decontamination and while wearing the respirator, fogging is occurring.Also, extra fibers are sticking out on the inside of the respirator causing skin irritation.The masks associated with this event were decontaminated with the battelle ccds "closed system" process.
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