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).On an unknown date approximately six months prior to the receipt of this report, the patient experienced a hernia.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 the patient experienced a hernia coincident with automated peritoneal dialysis therapy.It was not reported if the hernia occurred after beginning automated peritoneal dialysis therapy or prior to initiating automated peritoneal dialysis therapy.The cause of the hernia was not reported.It was not reported if the hernia worsened with peritoneal dialysis therapy.The patient was not hospitalized for the event.Treatment for the hernia event was not reported.The care plan for the event was that the patient would be visiting the physician on an unknown date and be evaluated for any treatment/action on the hernia.Dianeal therapy was ongoing.The patient was not recovered from the event.No additional information is available.
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Manufacturer Narrative
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(b)(4).The device was not returned for evaluation; therefore a device analysis could not be performed.The service history revealed no repetitive failures, no workmanship or process issues, and no similar complaints related to the reported problem.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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(b)(4).On an unreported date, the patient underwent outpatient surgery as a treatment of the hernia.At the time of this report the patient was recovering from this hernia event.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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