Catalog Number 955365 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Rash (2033)
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Event Type
Injury
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Manufacturer Narrative
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The event was reported to have occurred a few weeks ago, after therapy was changed from a non baxter product to theranova should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a patient experienced a ¿rise of keratynin factor¿ and a rash after patient treatment with theranova 400.The patient was hospitalized for seven days and was treated with unspecified fluid with antibiotics.The patient outcome was not reported.The defect was noticed after use.No further medical consequences were reported.No additional information is available.
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Manufacturer Narrative
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Reportedly the patient had been treated with theranova approximately 10 times after which the patient presented with rash on their entire body.It was reported that the patient was treated with antibiotics during hospitalization due to suspected inflammation.The sample was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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