Catalog Number 5C8310R |
Device Problem
Insufficient Information (3190)
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Patient Problem
Hernia (2240)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The patient was reported to have developed the hernia a couple of years ago.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 an abdominal hernia coincident with peritoneal dialysis therapy.The cause of the hernia was unknown.Although the hernia was noted to have developed prior to the start of peritoneal dialysis therapy, it was reported that the hernia worsened and began to bulge following the initiation of therapy.The patient was not hospitalized for the hernia.The patient underwent hernia repair surgery as treatment for the event.Dianeal therapy was ongoing.The patient was reported to have recovered from the hernia event.Additional information is not available at this time.
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Manufacturer Narrative
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(b)(4).The device was not returned; therefore, a device analysis could not be completed.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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