Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Diarrhea (1811); Headache (1880); High Blood Pressure/ Hypertension (1908); Nausea (1970)
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Event Date 01/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Udi and catalog information are unknown.Report source: manufacturing site address is unknown.Premarket (510k) number is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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Per a social media search, it was reported that the patient has pulmonary hypertension (ph) and has been on iv remodulin for the last 6 year.Patient has experienced severe headaches and diarrhea as the most prominent symptoms, and occasional nausea.
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Manufacturer Narrative
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Other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, this complaint will be reopened for further investigation.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.
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Search Alerts/Recalls
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