NATURA 420696Recalls & reported problems
Convatec, Purchasing Department · Natura® High Output Pouch Transparent W/1-Sided Comfort Panel W/ Filter 2 1/4" · Class 1
All models of NATURA (15)
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 00768455127597), received between Dec 13, 2021 and Dec 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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
- Material Too Rigid or Stiff1
Patient problems
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff
END USER STATED THAT TAP OF ONE POUCH WAS HARD AND DUG INTO HER SKIN. NO OPEN AREAS WERE REPORTED AND THERE WAS NO LEAKAGE INVOLVED. WEAR TIME WAS NOT PROVIDED. SHE DISCONTINUED THE PRODUCT AND WAS WEARING ANOTHER PRODUCT AND THE ISSUE WAS RESOLVED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Tissue Breakdown
MAUDE report 12982220 ↗
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
- ESTEEM SYNERGY+ 416779Convatec, Purchasing Department · POUCH, COLOSTOMY30 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
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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