ESTEEM+ 413521Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00768455130238), received between Mar 31, 2023 and Dec 2, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Material Disintegration; Material Too Rigid or Stiff; Material Disintegration; Material Too Rigid or Stiff

  THE END USER¿S FAMILY OR FRIEND REPORTED THAT FIVE OUT OF TEN MOLDABLE DISCS WERE DRIED OUT, BRITTLE AND WERE HARD TO MOLD TO APPLY AND BROKE OFF WITH REMOVAL. ALSO, HE STATED THAT ONCE APPLIED IT LEAKED WITHIN TWELVE TO TWENTY-FOUR HOURS AND AS THEY WERE TRYING TO REMOVE, THE MOLDABLE DISC WAS BREAKING OFF IN PIECES WITH SOME REMAINING STUCK TO THEIR SKIN. THE PRODUCT WAS USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690213 ↗
• MalfunctionDec 2, 2025Material Disintegration; Material Too Rigid or Stiff; Material Disintegration; Material Too Rigid or Stiff

  THE END USER¿S FAMILY OR FRIEND REPORTED THAT FIVE OUT OF TEN MOLDABLE DISCS WERE DRIED OUT, BRITTLE AND WERE HARD TO MOLD TO APPLY AND BROKE OFF WITH REMOVAL. ALSO, HE STATED THAT ONCE APPLIED IT LEAKED WITHIN TWELVE TO TWENTY-FOUR HOURS AND AS THEY WERE TRYING TO REMOVE, THE MOLDABLE DISC WAS BREAKING OFF IN PIECES WITH SOME REMAINING STUCK TO THEIR SKIN. THE PRODUCT WAS USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690212 ↗
• MalfunctionDec 2, 2025Material Disintegration; Material Too Rigid or Stiff; Material Disintegration; Material Too Rigid or Stiff

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690211 ↗
• MalfunctionDec 2, 2025Material Disintegration; Material Too Rigid or Stiff; Material Disintegration; Material Too Rigid or Stiff

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690210 ↗
• MalfunctionDec 2, 2025Material Disintegration; Material Too Rigid or Stiff; Material Disintegration; Material Too Rigid or Stiff

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690208 ↗
• MalfunctionMar 31, 2023Obstruction of Flow; Material Protrusion/Extrusion; Material Too Soft/Flexible; Obstruction of Flow; Material Protrusion/Extrusion; Material Too Soft/Flexible

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653412 ↗
• MalfunctionMar 31, 2023Obstruction of Flow; Material Protrusion/Extrusion; Material Too Soft/Flexible; Obstruction of Flow; Material Protrusion/Extrusion; Material Too Soft/Flexible

  THE END USER REPORTED THAT MOLDABLE MASS SWELLED AND COVERED STOMA AFTER ONE DAY OR LESS OF WEAR TIME. SHE HAD INITIALLY EXPERIENCED THE ISSUE WITH FIRST FOUR POUCHES FROM THE BOX AT HOME AND SHE HAD BEEN USED THIS COMPANY'S DEVICE SUCCESSFULLY SINCE (B)(6) 2022 AND FELT IT WEIRD AND BUT COULD NOT FOUND ANY SOLUTION TO RESOLVE THE ISSUE. HER STOOL CONSISTENTLY WAS LIKE THICK SAUCE, NOT LIQUID. SHE HAD PUT THE FIRST FRESH BAG ON, WITHIN FEW HOURS OF APPLICATION, SHE FELT HEAVINESS AND PULLING EFFECT, ALTHOUGH BAG WAS NOT FULL AND DIDN'T EVEN EAT A MEAL AT THAT TIME. THEN, SHE WENT TO CHECK AND OBSERVED THAT MATERIAL THAT HUGGED THE STOMA INSIDE WAS SWELLED RIGHT UP AND COVERED HER PROTRUDING ONE OR HALF INCH STOMA, DUE TO WHICH SHE CHANGED IT IMMEDIATELY AS SHE DIDN'T KNOW WHAT TO DO. SHE IS A SINGLE WOMAN IN HER FIFTIES, WEIGH AROUND 110 (WEIGHT UNITS UNKNOWN) WITH HEIGHT 5'7" AND SHE IS ON DISABILITY DUE TO WHICH SHE DOES NOT WANT TO JUST CHANGE A BAG IN A CARELESS WAY. ALTHOUGH HER DIET WAS EVEN AND SHE WAS TAKING LOPERAMIDE FOR MONTHS AND DIDN'T HAVE ANY ISSUES WITH THICKENING AGENTS THE DAY BEFORE, SHE OBSERVED THERE WAS NO STOOL BECAUSE THE STOMA OPENING WAS COVERED, AND SHE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653411 ↗
• MalfunctionMar 31, 2023Obstruction of Flow; Material Protrusion/Extrusion; Material Too Soft/Flexible; Obstruction of Flow; Material Protrusion/Extrusion; Material Too Soft/Flexible

  THE END USER REPORTED THAT MOLDABLE MASS SWELLED AND COVERED STOMA AFTER ONE DAY OR LESS OF WEAR TIME. SHE HAD INITIALLY EXPERIENCED THE ISSUE WITH FIRST FOUR POUCHES FROM THE BOX AT HOME AND SHE HAD BEEN USED THIS COMPANY'S DEVICE SUCCESSFULLY SINCE (B)(6) 2022 AND FELT IT WEIRD AND BUT COULD NOT FOUND ANY SOLUTION TO RESOLVE THE ISSUE. HER STOOL CONSISTENTLY WAS LIKE THICK SAUCE, NOT LIQUID. SHE HAD PUT THE FIRST FRESH BAG ON, WITHIN FEW HOURS OF APPLICATION, SHE FELT HEAVINESS AND PULLING EFFECT, ALTHOUGH BAG WAS NOT FULL AND DIDN'T EVEN EAT A MEAL AT THAT TIME. THEN, SHE WENT TO CHECK AND OBSERVED THAT MATERIAL THAT HUGGED THE STOMA INSIDE WAS SWELLED RIGHT UP AND COVERED HER PROTRUDING ONE OR HALF INCH STOMA, DUE TO WHICH SHE CHANGED IT IMMEDIATELY AS SHE DIDN'T KNOW WHAT TO DO. SHE IS A SINGLE WOMAN IN HER FIFTIES, WEIGH AROUND 110 (WEIGHT UNITS UNKNOWN) WITH HEIGHT 5'7" AND SHE IS ON DISABILITY DUE TO WHICH SHE DOES NOT WANT TO JUST CHANGE A BAG IN A CARELESS WAY. ALTHOUGH HER DIET WAS EVEN AND SHE WAS TAKING LOPERAMIDE FOR MONTHS AND DIDN'T HAVE ANY ISSUES WITH THICKENING AGENTS THE DAY BEFORE, SHE OBSERVED THERE WAS NO STOOL BECAUSE THE STOMA OPENING WAS COVERED, AND SHE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653399 ↗
• MalfunctionMar 31, 2023Obstruction of Flow; Material Protrusion/Extrusion; Material Too Soft/Flexible; Obstruction of Flow; Material Protrusion/Extrusion; Material Too Soft/Flexible

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653398 ↗