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Device Problem
Degraded (1153)
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Patient Problems
Asthma (1726); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Dizziness (2194); Nodule (4551)
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Event Date 10/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972, z-1973, and z-1974.H3 other text : device not returned to manufacturer.
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Event Description
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The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging of eye irritation; dizziness and/or headache; hypersensitivity; asthma (new or worsening); inflammatory response nodule on lung.The manufacturer was made aware of this complaint through a representative of the customer.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Search Alerts/Recalls
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