Leg Bag 151919Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741050916), received between Feb 9, 2018 and Feb 23, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2018No Flow

  IT WAS REPORTED THAT URINE WOULD NOT DRAIN INTO THE DRAIN BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7291809 ↗
• MalfunctionFeb 9, 2018Leak/Splash; Infusion or Flow Problem

  IT WAS REPORTED THAT URINE BACKFLOWS OUT OF THE DRAIN BAG AND THAT THE DRAIN BAG LEAKED FROM THE TUBING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7259259 ↗