Catalog Number 0220180518 |
Device Problems
Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Renal Failure (2041); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the patient exhibited renal failure after surgery.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient exhibited renal failure after surgery.Probable root cause: incorrect device dimensions; incorrect catheter durometer; incorrect device used; manufacturing nonconformity; (e.G.Incorrect hydrophilic coating); improper storage or shipping conditions.Manufacture date is not known.H3 other text: 81.
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Event Description
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It was reported that the patient exhibited renal failure after surgery.
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Search Alerts/Recalls
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