Catalog Number 934070 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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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 a six-month-old experienced an unspecified infection after undergoing heart surgery ¿single ventricle case¿ in which coseal was used.The physician reported the infection occurred ¿while spraying coseal¿.The cause of the event was not reported.It was not reported if there was any medical intervention.No further detail was provided regarding treatment if hospitalization was required or the patient outcome.No additional information is available.
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Manufacturer Narrative
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H10: the device was not returned and the lot number is unknown; therefore, a device 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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