ESTEEM SYNERGY 409269Recalls & reported problems
Convatec, Purchasing Department · Esteem Synergy® Durahesive® Moldable Convex Skin Barrier With White Flexible Collar / Medium · Class 1
Quick summary
This Convatec Esteem Synergy moldable convex skin barrier is a wafer worn over a stoma. Most of the 29 reports describe the barrier sitting in the wrong position, and a few describe material that felt too stiff or did not mold to the stoma shape as expected, with leakage and skin redness noted in one case. There are no deaths and no reported injuries. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00768455105243), received between Nov 7, 2018 and Dec 6, 2024 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (28 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.
Reports received per month
Most reported problems
Device problems
- Malposition of Device28
- Fluid/Blood Leak1
- Material Too Rigid or Stiff1
Patient problems
- No Consequences Or Impact To Patient24
- No Patient Involvement4
- Erythema1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2024Fluid/Blood Leak; Material Too Rigid or Stiff; Fluid/Blood Leak; Material Too Rigid or Stiff
THE WIFE OF END USER REPORTED THAT THE MASS WAS LESS PLIABLE PRIOR TO USE. THE END USER USED THE WAFERS AND NOTED THEY DID NOT MOLD TO FIT THE STOMA SIZE AND SHAPE AS PRECISELY COMPARED TO PREVIOUS WAFERS USED. SHE STATED AS A RESULT OF THE MASS BEING LESS PLIABLE, END USER DEVELOPED REDNESS TO THE IMMEDIATE PERISTOMAL SKIN. END USER'S WIFE, ALSO STATED THE SKIN IRRITATION WAS A RESULT OF LEAKAGE OF THE PRODUCT. USUAL WEAR TIME WAS THREE-FOUR DAYS. THE END USER USED COMPANY'S ADHESIVE REMOVER, WATER TO CLEANSE SKIN, ABSORPTIVE AND PROTECTIVE POWDER, COMPANY'S BARRIER WIPE, AND COMPANY'S BARRIER STRIPS. HE DID CONNECTS TO NIGHT DRAINAGE. WIFE REPORTED THAT SHE FIRST NOTED THIS APPROXIMATELY ONE MONTH AGO. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Erythema; Skin Inflammation/ Irritation
MAUDE report 20861579 ↗MalfunctionNov 21, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9353197 ↗MalfunctionNov 21, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9353194 ↗MalfunctionNov 21, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9353193 ↗MalfunctionNov 21, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9353192 ↗MalfunctionNov 21, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9353190 ↗MalfunctionNov 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9333908 ↗MalfunctionNov 18, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9333905 ↗MalfunctionNov 6, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9285359 ↗MalfunctionNov 6, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9285356 ↗MalfunctionMay 22, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8632984 ↗MalfunctionMay 6, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8583750 ↗MalfunctionMay 6, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8583749 ↗MalfunctionMay 1, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8570228 ↗MalfunctionMay 1, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8570225 ↗MalfunctionMay 1, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8570154 ↗MalfunctionMay 1, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8570152 ↗MalfunctionMay 1, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8570151 ↗MalfunctionMay 1, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8570150 ↗MalfunctionMar 13, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE IS OFF CENTER AND MASS PREMATURELY DISINTEGRATES IN THE AREA IN WHICH THERE IS A SMALLER AMOUNT OF BARRIER. NO HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8416294 ↗MalfunctionJan 22, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8267675 ↗MalfunctionJan 22, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8267674 ↗MalfunctionJan 22, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8267633 ↗MalfunctionJan 22, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8267626 ↗MalfunctionNov 7, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT "STARTER HOLE IS OFF-CENTER BY APPROX 1/4 TO 1/2 INCH." NO HARM REPORTED. NO PHOTOS WERE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8045755 ↗
Other PROTECTOR, OSTOMY devices
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- SUR-FIT NATURA 413182Convatec, Purchasing Department · PROTECTOR, OSTOMY1,202 reports
- SUR-FIT NATURA 413180Convatec, Purchasing Department · PROTECTOR, OSTOMY1,190 reports
- SUR-FIT NATURA 413179Convatec, Purchasing Department · PROTECTOR, OSTOMY1,178 reports
- SUR-FIT NATURA 413181Convatec, Purchasing Department · PROTECTOR, OSTOMY974 reports
- NATURA 411802Convatec, Purchasing Department · PROTECTOR, OSTOMY966 reports
- NATURA 404592Convatec, Purchasing Department · PROTECTOR, OSTOMY907 reports
- SUR-FIT NATURA 413183Convatec, Purchasing Department · PROTECTOR, OSTOMY773 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.