ESTEEM+ 413515Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00768455130177), received between Oct 14, 2022 and Oct 14, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022Material Disintegration; Material Disintegration

  THE END USER REPORTED THAT HE HAD RECEIVED ONE MARKET UNIT FROM DOCTOR OF MEDICINE (MD) UPON DISCHARGE FOR HIS RECENT OSTOMY SURGERY. HE PREVIOUSLY USED A MEDIUM SIZE APPLIANCE, BUT HIS STOMA IS NOW 28X30 MM. FURTHER, HE STATED THAT WHILE CHANGING HIS POUCH, THE MOLDABLE DISC WAS CRUMBLING DURING THE MOLDING PHASE. TWO OF THE BARRIERS WERE RUINED WHILE TRYING TO MOLD THE APPLIANCE. HIS HUSBAND WAS ABLE TO GET THE THIRD ONE TO MOLD ALTHOUGH IT WAS NOT AS EASY AS EXPECTED AND THAT THIRD ONE WAS IN PLACE WITHOUT ANY CURRENT EVIDENCE OF LEAKAGE. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15603087 ↗
• MalfunctionOct 14, 2022Material Disintegration; Material Disintegration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15603086 ↗
• MalfunctionOct 14, 2022Material Disintegration; Material Disintegration

  THE END USER REPORTED THAT HE HAD RECEIVED ONE MARKET UNIT FROM DOCTOR OF MEDICINE (MD) UPON DISCHARGE FOR HIS RECENT OSTOMY SURGERY. HE PREVIOUSLY USED A MEDIUM SIZE APPLIANCE, BUT HIS STOMA IS NOW 28X30 MM. FURTHER, HE STATED THAT WHILE CHANGING HIS POUCH, THE MOLDABLE DISC WAS CRUMBLING DURING THE MOLDING PHASE. TWO OF THE BARRIERS WERE RUINED WHILE TRYING TO MOLD THE APPLIANCE. HIS HUSBAND WAS ABLE TO GET THE THIRD ONE TO MOLD ALTHOUGH IT WAS NOT AS EASY AS EXPECTED AND THAT THIRD ONE WAS IN PLACE WITHOUT ANY CURRENT EVIDENCE OF LEAKAGE. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15603083 ↗