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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Skin Discoloration (2074); Cough (4457); Skin Inflammation/ Irritation (4545)
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Event Date 08/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device not returned.Ccds staff has been in contact with the hcp, explaining the decontamination process, the chemicals used (including sdss), provided a link to faqs for hcps as well as advised that some hcps air the bags of masks out 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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Event Description
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User reported rash, skin itching, bumps, redness from mouth itching, cough, weakness, itchy and water eyes.The masks associated with this event were decontaminated with the battelle ccds "closed system" process.
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Search Alerts/Recalls
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