ESTEEM 421631Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00768455146093), received between Jan 20, 2023 and Jan 20, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213097 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

  THIS EMDR IS BEING SUBMITTED FOR FIFTEEN APPLIANCES FROM TWO MARKET UNITS WITH SAME COMPANY'S KNOWN LOT. THE END USER REPORTED TO RETAILER WHO, AFTERWARDS, REPORTED TO COMPANY THAT AFTER APPLICATION OF CUT-TO-FIT WATER, BROWN MATERIAL AROUND THE STOMA SEEMED TO MELT AND WAFER OPENING GRADUALLY CLOSED OVER HIS STOMA. HE STATED THAT HE CUT THE OPENING OF THE WAFER TO ONE-INCH AND ON THE SECOND DAY AFTER APPLICATION THE ONE-INCH HOLE OF WAFER AROUND THE STOMA HAD DECREASED IN SIZE TO ONE AND HALF INCH AND IT ALMOST COVERED HIS STOMA. THE END USER, ON FURTHER REQUESTING AN ADDITIONAL INFORMATION, REPORTED THAT THE STOMA SIZE WAS TWENTY-FIVE MM OR ONE INCH. HE REPORTED THAT WHEN HE REMOVED THE WAFER ON THE FOURTH DAY, THE WAFER CLOSED OVER HIS FLUSH STOMA AND DUE TO THAT THE OUTPUT WAS OBSTRUCTED. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT WAS NEEDED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213096 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

  THIS EMDR IS BEING SUBMITTED FOR FIFTEEN APPLIANCES FROM TWO MARKET UNITS WITH SAME COMPANY'S KNOWN LOT. THE END USER REPORTED TO RETAILER WHO, AFTERWARDS, REPORTED TO COMPANY THAT AFTER APPLICATION OF CUT-TO-FIT WATER, BROWN MATERIAL AROUND THE STOMA SEEMED TO MELT AND WAFER OPENING GRADUALLY CLOSED OVER HIS STOMA. HE STATED THAT HE CUT THE OPENING OF THE WAFER TO ONE-INCH AND ON THE SECOND DAY AFTER APPLICATION THE ONE-INCH HOLE OF WAFER AROUND THE STOMA HAD DECREASED IN SIZE TO ONE AND HALF INCH AND IT ALMOST COVERED HIS STOMA. THE END USER, ON FURTHER REQUESTING AN ADDITIONAL INFORMATION, REPORTED THAT THE STOMA SIZE WAS TWENTY-FIVE MM OR ONE INCH. HE REPORTED THAT WHEN HE REMOVED THE WAFER ON THE FOURTH DAY, THE WAFER CLOSED OVER HIS FLUSH STOMA AND DUE TO THAT THE OUTPUT WAS OBSTRUCTED. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT WAS NEEDED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213095 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213094 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

  THIS EMDR IS BEING SUBMITTED FOR FIFTEEN APPLIANCES FROM TWO MARKET UNITS WITH SAME COMPANY'S KNOWN LOT. THE END USER REPORTED TO RETAILER WHO, AFTERWARDS, REPORTED TO COMPANY THAT AFTER APPLICATION OF CUT-TO-FIT WATER, BROWN MATERIAL AROUND THE STOMA SEEMED TO MELT AND WAFER OPENING GRADUALLY CLOSED OVER HIS STOMA. HE STATED THAT HE CUT THE OPENING OF THE WAFER TO ONE-INCH AND ON THE SECOND DAY AFTER APPLICATION THE ONE-INCH HOLE OF WAFER AROUND THE STOMA HAD DECREASED IN SIZE TO ONE AND HALF INCH AND IT ALMOST COVERED HIS STOMA. THE END USER, ON FURTHER REQUESTING AN ADDITIONAL INFORMATION, REPORTED THAT THE STOMA SIZE WAS TWENTY-FIVE MM OR ONE INCH. HE REPORTED THAT WHEN HE REMOVED THE WAFER ON THE FOURTH DAY, THE WAFER CLOSED OVER HIS FLUSH STOMA AND DUE TO THAT THE OUTPUT WAS OBSTRUCTED. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT WAS NEEDED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213093 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213092 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213091 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213090 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

  THIS EMDR IS BEING SUBMITTED FOR FIFTEEN APPLIANCES FROM TWO MARKET UNITS WITH SAME COMPANY'S KNOWN LOT. THE END USER REPORTED TO RETAILER WHO, AFTERWARDS, REPORTED TO COMPANY THAT AFTER APPLICATION OF CUT-TO-FIT WATER, BROWN MATERIAL AROUND THE STOMA SEEMED TO MELT AND WAFER OPENING GRADUALLY CLOSED OVER HIS STOMA. HE STATED THAT HE CUT THE OPENING OF THE WAFER TO ONE-INCH AND ON THE SECOND DAY AFTER APPLICATION THE ONE-INCH HOLE OF WAFER AROUND THE STOMA HAD DECREASED IN SIZE TO ONE AND HALF INCH AND IT ALMOST COVERED HIS STOMA. THE END USER, ON FURTHER REQUESTING AN ADDITIONAL INFORMATION, REPORTED THAT THE STOMA SIZE WAS TWENTY-FIVE MM OR ONE INCH. HE REPORTED THAT WHEN HE REMOVED THE WAFER ON THE FOURTH DAY, THE WAFER CLOSED OVER HIS FLUSH STOMA AND DUE TO THAT THE OUTPUT WAS OBSTRUCTED. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT WAS NEEDED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213089 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

  THIS EMDR IS BEING SUBMITTED FOR FIFTEEN APPLIANCES FROM TWO MARKET UNITS WITH SAME COMPANY'S KNOWN LOT. THE END USER REPORTED TO RETAILER WHO, AFTERWARDS, REPORTED TO COMPANY THAT AFTER APPLICATION OF CUT-TO-FIT WATER, BROWN MATERIAL AROUND THE STOMA SEEMED TO MELT AND WAFER OPENING GRADUALLY CLOSED OVER HIS STOMA. HE STATED THAT HE CUT THE OPENING OF THE WAFER TO ONE-INCH AND ON THE SECOND DAY AFTER APPLICATION THE ONE-INCH HOLE OF WAFER AROUND THE STOMA HAD DECREASED IN SIZE TO ONE AND HALF INCH AND IT ALMOST COVERED HIS STOMA. THE END USER, ON FURTHER REQUESTING AN ADDITIONAL INFORMATION, REPORTED THAT THE STOMA SIZE WAS TWENTY-FIVE MM OR ONE INCH. HE REPORTED THAT WHEN HE REMOVED THE WAFER ON THE FOURTH DAY, THE WAFER CLOSED OVER HIS FLUSH STOMA AND DUE TO THAT THE OUTPUT WAS OBSTRUCTED. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT WAS NEEDED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213088 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213087 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213086 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

  THIS EMDR IS BEING SUBMITTED FOR FIFTEEN APPLIANCES FROM TWO MARKET UNITS WITH SAME COMPANY'S KNOWN LOT. THE END USER REPORTED TO RETAILER WHO, AFTERWARDS, REPORTED TO COMPANY THAT AFTER APPLICATION OF CUT-TO-FIT WATER, BROWN MATERIAL AROUND THE STOMA SEEMED TO MELT AND WAFER OPENING GRADUALLY CLOSED OVER HIS STOMA. HE STATED THAT HE CUT THE OPENING OF THE WAFER TO ONE-INCH AND ON THE SECOND DAY AFTER APPLICATION THE ONE-INCH HOLE OF WAFER AROUND THE STOMA HAD DECREASED IN SIZE TO ONE AND HALF INCH AND IT ALMOST COVERED HIS STOMA. THE END USER, ON FURTHER REQUESTING AN ADDITIONAL INFORMATION, REPORTED THAT THE STOMA SIZE WAS TWENTY-FIVE MM OR ONE INCH. HE REPORTED THAT WHEN HE REMOVED THE WAFER ON THE FOURTH DAY, THE WAFER CLOSED OVER HIS FLUSH STOMA AND DUE TO THAT THE OUTPUT WAS OBSTRUCTED. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT WAS NEEDED. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213084 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213083 ↗
• MalfunctionJan 20, 2023Complete Blockage; Melted; Complete Blockage; Melted

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213082 ↗