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Device Problem
Degraded (1153)
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Patient Problems
Unspecified Respiratory Problem (4464); Eye Pain (4467); Nodule (4551)
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Event Date 03/02/2019 |
Event Type
Injury
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Manufacturer Narrative
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No device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.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 a voluntary medwatch report (mw5151098).The patient is alleging development of four nodules on their thyroid glands.Biopsy has not been performed.The patient also alleges that the device affects some implanted medical equipment but is uncertain which ones.The patient has undergone two cataract surgeries but wasn't successful and that their eyes itch and burn and hurt all the time.They are also losing teeth.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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