NATURA+ 416416Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00768455113347), received between Jun 18, 2025 and Jun 18, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Fluid/Blood Leak; Sharp Edges; Fluid/Blood Leak; Sharp Edges

  THE END USER REPORTED FOUR POUCHES OUTLET STRIPS WERE CRACKED, SHE STATED THIS ISSUE OCCURRED ON SECOND DAY OF USE. SHE STARTED USING THE POUCHES THAT HAVE THE STRAIGHT OUTLET STRIPS AND STARTED TO GET LEAKAGE. SHE WAS UNSURE IF THE LEAKAGE WAS COMING FROM BETWEEN THE OUTLET STRIP AND THE SEAM AROUND THE OUTLET STRIP OR IF IT OCCURRED BECAUSE THE OUTLET STRIPS BECOME SHARP AND PUNCTURED THE POUCH FILM WHEN IT WAS FOLDED UP WHICH SHE HAD VISUALIZED. IT STARTED WITH THE STRIP CRACKED AND BROKEN INTO PIECES THAT WERE SHARP LIKE PAPER CUTS.THE END USER REPORTED THAT THIS WAS THE FOURTH POUCH OUT OF THIS BOX THAT THIS HAD HAPPENED WITH. THE FIRST THREE WERE NOT AS BAD AS THIS ISSUE AND SHE WAS NOT SURE IF IT WAS A LEAK OR HAPPENED BY SOME DROPPED STOOL ON THE TOILET SEAT. THE PRODUCT WAS USED BY THE PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283610 ↗
• MalfunctionJun 18, 2025Fluid/Blood Leak; Sharp Edges; Fluid/Blood Leak; Sharp Edges

  THE END USER REPORTED FOUR POUCHES OUTLET STRIPS WERE CRACKED, SHE STATED THIS ISSUE OCCURRED ON SECOND DAY OF USE. SHE STARTED USING THE POUCHES THAT HAVE THE STRAIGHT OUTLET STRIPS AND STARTED TO GET LEAKAGE. SHE WAS UNSURE IF THE LEAKAGE WAS COMING FROM BETWEEN THE OUTLET STRIP AND THE SEAM AROUND THE OUTLET STRIP OR IF IT OCCURRED BECAUSE THE OUTLET STRIPS BECOME SHARP AND PUNCTURED THE POUCH FILM WHEN IT WAS FOLDED UP WHICH SHE HAD VISUALIZED. IT STARTED WITH THE STRIP CRACKED AND BROKEN INTO PIECES THAT WERE SHARP LIKE PAPER CUTS. THE END USER REPORTED THAT THIS WAS THE FOURTH POUCH OUT OF THIS BOX THAT THIS HAD HAPPENED WITH. THE FIRST THREE WERE NOT AS BAD AS THIS ISSUE AND SHE WAS NOT SURE IF IT WAS A LEAK OR HAPPENED BY SOME DROPPED STOOL ON THE TOILET SEAT. THE PRODUCT WAS USED BY THE PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283470 ↗
• MalfunctionJun 18, 2025Fluid/Blood Leak; Sharp Edges; Fluid/Blood Leak; Sharp Edges

  THE END USER REPORTED FOUR POUCHES OUTLET STRIPS WERE CRACKED, SHE STATED THIS ISSUE OCCURRED ON SECOND DAY OF USE. SHE STARTED USING THE POUCHES THAT HAVE THE STRAIGHT OUTLET STRIPS AND STARTED TO GET LEAKAGE. SHE WAS UNSURE IF THE LEAKAGE WAS COMING FROM BETWEEN THE OUTLET STRIP AND THE SEAM AROUND THE OUTLET STRIP OR IF IT OCCURRED BECAUSE THE OUTLET STRIPS BECOME SHARP AND PUNCTURED THE POUCH FILM WHEN IT WAS FOLDED UP WHICH SHE HAD VISUALIZED. IT STARTED WITH THE STRIP CRACKED AND BROKEN INTO PIECES THAT WERE SHARP LIKE PAPER CUTS.THE END USER REPORTED THAT THIS WAS THE FOURTH POUCH OUT OF THIS BOX THAT THIS HAD HAPPENED WITH. THE FIRST THREE WERE NOT AS BAD AS THIS ISSUE AND SHE WAS NOT SURE IF IT WAS A LEAK OR HAPPENED BY SOME DROPPED STOOL ON THE TOILET SEAT. THE PRODUCT WAS USED BY THE PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283451 ↗
• MalfunctionJun 18, 2025Fluid/Blood Leak; Sharp Edges; Fluid/Blood Leak; Sharp Edges

  THE END USER REPORTED FOUR POUCHES OUTLET STRIPS WERE CRACKED, SHE STATED THIS ISSUE OCCURRED ON SECOND DAY OF USE. SHE STARTED USING THE POUCHES THAT HAVE THE STRAIGHT OUTLET STRIPS AND STARTED TO GET LEAKAGE. SHE WAS UNSURE IF THE LEAKAGE WAS COMING FROM BETWEEN THE OUTLET STRIP AND THE SEAM AROUND THE OUTLET STRIP OR IF IT OCCURRED BECAUSE THE OUTLET STRIPS BECOME SHARP AND PUNCTURED THE POUCH FILM WHEN IT WAS FOLDED UP WHICH SHE HAD VISUALIZED. IT STARTED WITH THE STRIP CRACKED AND BROKEN INTO PIECES THAT WERE SHARP LIKE PAPER CUTS. THE END USER REPORTED THAT THIS WAS THE FOURTH POUCH OUT OF THIS BOX THAT THIS HAD HAPPENED WITH. THE FIRST THREE WERE NOT AS BAD AS THIS ISSUE AND SHE WAS NOT SURE IF IT WAS A LEAK OR HAPPENED BY SOME DROPPED STOOL ON THE TOILET SEAT. THE PRODUCT WAS USED BY THE PATIENT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283450 ↗