Model Number UPC#681131436359 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
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Event Date 05/24/2022 |
Event Type
Injury
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Event Description
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On the initial report received by aso on (b)(6) 2022 consumer reported that product caused an allergic reaction (burning sensation).Consumer stated that she applied the product to protect her nose when using the n95 mask.Consumer went to the hospital because of the burning sensation.
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Manufacturer Narrative
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As of (b)(6) 2022 retained samples were submitted to the lab for testing, with no defects noted.In addition, aso has reviewed records of biocompatibility tests and latex screening.Refer to relevant tests/laboratory data of this report for further details.
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Manufacturer Narrative
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As of on (b)(6) 2022, retained samples were submitted to the lab for testing, with no defects noted.In addition, aso has reviewed records of biocompatibility tests and latex screening.Refer to section b.6 of this report for further details.As of 08/05/2022, unused returned product was submitted to the lab for testing, with no defects noted.
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Event Description
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On the initial report received by aso on 05/24/2022 consumer reported that product caused an allergic reaction (burning sensation).Consumer stated that she applied the product to protect her nose when using the n95 mask.Consumer went to the hospital because of the burning sensation.On completed cir received on 7/11/2022 consumer stated the issue was with the pad area.She added the symptoms corrected after stopped using the product but she still has a mark on her nose.
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Search Alerts/Recalls
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