Udi and catalog information are unknown.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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Per a social media search, it was reported that while on remodulin, the patient experienced headache, chills, nausea, leg or foot pain, and flushing.Patient advised that in their experience, all of those fade once you are on a stable dose for a bit.The one that sticks around is the jaw pain.
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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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