Device Problems
Nonstandard Device (1420); Insufficient Information (3190)
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Patient Problem
Peritonitis (2252)
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Event Date 09/29/2013 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The attorney alleged that the suspect device was part of a recall.However, product-specific information is not provided and as such it cannot be determined if the device was part of the recall and what z number was assigned.A supplemental report will be submitted upon completion of the plant's investigation.Additional information has been requested and will be submitted upon receipt accordingly.This is one of two device reports for this event.
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Event Description
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The plaintiff's attorney alleged the patient experienced peritonitis from the use of the product, approximately 1 year after starting peritoneal dialysis.The patient was admitted to the hospital after noting severe abdominal pain.The hospital noted the peritonitis was caused by pseudomonas aeruginosa in dialysate fluid.
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Manufacturer Narrative
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Further attempts to obtain complete complaint details and upon receipt will be submitted accordingly.This is one of two device reports associated with this event.Related manufacturer report numbers are 2937457-2016-00385 and 8030665-2016-00170.
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Search Alerts/Recalls
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