ESENTA 423285/7Recalls & reported problems
Convatec, Purchasing Department · Esenta™ Skin Barrier Foam Applicator 3 ml, Sterile (25 per pack) · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455197361), received between May 26, 2023 and May 26, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Flare or Flash” (1 report).
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
- Flare or Flash1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2023Flare or Flash; Flare or Flash
THE NURSE REPORTED THAT THE SURGEON HAD APPLIED THE COMPANY'S KNOWN SKIN BARRIER FOAM APPLICATOR (STING FREE) AROUND THE WOUND OF THE PATIENT BEFORE SECURING THE VACUUM-ASSISTED CLOSURE (VAC) SYSTEM AND USED AN ELECTRIC CAUTERY DEVICE (DIATHERMY) FOR ONE BUTTON PUSH ONLY ON THE EDGE OF THE WOUND, DUE TO THIS, THE FOAM APPLICATOR ON THE SKIN AND THE WOUND SPONGE CAUGHT ON FIRE. THIS RESULTED IN A BURN INJURY TO THE PATIENT. THE PRODUCT WAS NOT RETURNED. NO PHOTO WAS AVAILABLE AT THIS TIME.
Patient problems: Burn(s)
MAUDE report 17008602 ↗
Other PROTECTOR, OSTOMY devices
- NATURA 404593Convatec, Purchasing Department · PROTECTOR, OSTOMY2,403 reports
- 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 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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