EchoNous Bladder Probe P005600Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09353278000113), received between Jun 10, 2021 and Jun 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Output Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2021Output Problem

  PATIENT HAD NOT PRODUCED ANY URINE FROM HIS FOLEY CATHETER FOR OVER 8 HOURS. BLADDER SCANNER HAD A RESULT OF 18 THEN ABOUT 25 CC OF URINE PRESENT IN HIS BLADDER. THIS PATIENT HAD HAD A BLADDER REPAIR IN ADDITION OF BOWEL SURGERY AND THE RESULTS OF THE BLADDER SCANNER MADE THE ON-CALL TELEHOSPITALIST CALL THE IN-HOUSE HOSPITALIST FOR A REFERRAL. A STAT CT OF HIS ABDOMEN AND AN X-RAY WERE ORDERED TO RULE OUT KIDNEY FAILURE AND A IV FLUID BOLUS WAS ORDERED. IT MUST BE NOTED THAT THIS PATIENT ALSO HAD AN NGT FOR AN ILEUS. WHEN THE PATIENT RETURNED FROM THE IMAGING EXAMS, WE RECEIVED AN ORDER TO FLUSH THE CATHETER. ALMOST IMMEDIATELY ABOUT 400CC OF URINE FLOWED INTO THE CATHETER BAG.

  Patient problems: Urinary Retention

  MAUDE report 11980131 ↗