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Catalog Number 638005 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930)
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Event Type
Injury
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Event Description
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A patient underwent a gynecological tumor resection surgery in which seprafilm was used.It was further reported the seprafilm was used on the pelvic floor.Several days following the surgery, the patient developed a fever and intraperitoneal infection.Drainage was performed.On an unknown date, the patient was discharged from the hospital.At the time of this report, the patient outcome was not reported.No additional information is available.
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Manufacturer Narrative
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The events occurred on an unspecified date in (b)(6) 2022.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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