ESTEEM SYNERGY+ 416779Recalls & reported problems
Convatec, Purchasing Department · ESTEEM SYN+ PCH CLDWFSTDTAN 48MM(1X30)US · Class 1
All models of ESTEEM SYNERGY (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec Esteem Synergy+ colostomy pouch is a one-piece pouch worn over a stoma. The 30 reports describe the pouch material feeling rough, stiff and uncomfortable against the skin, like hard cardboard, with pain mentioned in each report. There are no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00768455114658), received between Sep 22, 2022 and Nov 25, 2022 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (30 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
Device problems
- Material Too Rigid or Stiff30
Patient problems
- Pain30
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15864010 ↗MalfunctionNov 25, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15863998 ↗MalfunctionSep 28, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15499684 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15476975 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15476704 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15476545 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15476281 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15476223 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15476199 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15476157 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15476129 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15476118 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15476105 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15476102 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15476064 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15476030 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15475942 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15475941 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15475877 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15475619 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15475548 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15475545 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15475532 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
THE END USER REPORTED THAT THE MATERIAL OF THIRTY POUCHES WAS VERY ROUGH AND UNPLEASANT JUST LIKE THE HARD CARTON WITH NO FLEXIBILITY. ALTHOUGH, THE ROUGH POUCHES DID NOT CAUSE ANY HARM TO THE CUSTOMER HOWEVER, HE FELT VERY UNCOMFORTABLE. THE PRODUCT WAS USED BY CUSTOMER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: Pain
MAUDE report 15475520 ↗MalfunctionSep 24, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 15475305 ↗
Other POUCH, COLOSTOMY devices
- ACTIVELIFE 175778Convatec, Purchasing Department · POUCH, COLOSTOMY40 reports
- ACTIVELIFE 175777Convatec, Purchasing Department · POUCH, COLOSTOMY40 reports
- ACTIVELIFE 175779Convatec, Purchasing Department · POUCH, COLOSTOMY39 reports
- ACTIVELIFE 175782Convatec, Purchasing Department · POUCH, COLOSTOMY19 reports
- FLEXI-SEAL 418000Convatec, Purchasing Department · POUCH, COLOSTOMY16 reports
- ACTIVELIFE 175780Convatec, Purchasing Department · POUCH, COLOSTOMY10 reports
- ACTIVELIFE 175784Convatec, Purchasing Department · POUCH, COLOSTOMY5 reports
- NATURA 420696Convatec, Purchasing Department · POUCH, COLOSTOMY1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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