NATURA+ 416419Recalls & reported problems
Convatec, Purchasing Department · Natura®+ Drainable Pouch With Invisiclose® And Filter, Transparent, Standard 57Mm, 2 1/4 In · Class 1
All models of NATURA (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00768455113378), received between Nov 20, 2024 and Nov 20, 2024 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Sharp Edges” (10 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.
Reports received per month
Most reported problems
Device problems
- Sharp Edges10
Patient problems
- Abrasion10
- Hemorrhage/Blood Loss/Bleeding10
- Pressure Sore/Ulcer10
- Skin Inflammation/ Irritation10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2024Sharp Edges; Sharp Edges
THE END USER REPORTED THAT THE TAIL CLOSURE (SHARP CORNER EDGE OF OUTLET STRIP) CAUSED RUBBING ON THE RIGHT LEG/FOOT. THE AREA GOT SORE LEADING TO IRRITATION AND SMALL AMOUNT OF BLEEDING THAT STOPPED WITH PRESSURE, SHE COMPARED TO "SKINNING HER LEG SUCH AS WITH A FALL". SHE USED A PRESCRIPTION MEDICATION CLOBETASOL PROPIONATE THAT WAS PRESCRIBED FOR A DIFFERENT INDICATION TO TREAT IT. THE CONSUMER IS A NEWER USER AND DENIED ANY VISIBLE DEFECT TO THE OUTLET STRIP. SHE STATED THAT ALL POUCHES IN THE BOX WERE AFFECTED WITH IRRITATION OCCURRING WITHIN THE FIRST DAY OF USE. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer; Skin Inflammation/ Irritation
MAUDE report 20731759 ↗MalfunctionNov 20, 2024Sharp Edges; Sharp Edges
THE END USER REPORTED THAT THE TAIL CLOSURE (SHARP CORNER EDGE OF OUTLET STRIP) CAUSED RUBBING ON THE RIGHT LEG/FOOT. THE AREA GOT SORE LEADING TO IRRITATION AND SMALL AMOUNT OF BLEEDING THAT STOPPED WITH PRESSURE, SHE COMPARED TO "SKINNING HER LEG SUCH AS WITH A FALL". SHE USED A PRESCRIPTION MEDICATION CLOBETASOL PROPIONATE THAT WAS PRESCRIBED FOR A DIFFERENT INDICATION TO TREAT IT. THE CONSUMER IS A NEWER USER AND DENIED ANY VISIBLE DEFECT TO THE OUTLET STRIP. SHE STATED THAT ALL POUCHES IN THE BOX WERE AFFECTED WITH IRRITATION OCCURRING WITHIN THE FIRST DAY OF USE. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer; Skin Inflammation/ Irritation
MAUDE report 20731758 ↗MalfunctionNov 20, 2024Sharp Edges; Sharp Edges
THE END USER REPORTED THAT THE TAIL CLOSURE (SHARP CORNER EDGE OF OUTLET STRIP) CAUSED RUBBING ON THE RIGHT LEG/FOOT. THE AREA GOT SORE LEADING TO IRRITATION AND SMALL AMOUNT OF BLEEDING THAT STOPPED WITH PRESSURE, SHE COMPARED TO "SKINNING HER LEG SUCH AS WITH A FALL". SHE USED A PRESCRIPTION MEDICATION CLOBETASOL PROPIONATE THAT WAS PRESCRIBED FOR A DIFFERENT INDICATION TO TREAT IT. THE CONSUMER IS A NEWER USER AND DENIED ANY VISIBLE DEFECT TO THE OUTLET STRIP. SHE STATED THAT ALL POUCHES IN THE BOX WERE AFFECTED WITH IRRITATION OCCURRING WITHIN THE FIRST DAY OF USE. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer; Skin Inflammation/ Irritation
MAUDE report 20731757 ↗MalfunctionNov 20, 2024Sharp Edges; Sharp Edges
THE END USER REPORTED THAT THE TAIL CLOSURE (SHARP CORNER EDGE OF OUTLET STRIP) CAUSED RUBBING ON THE RIGHT LEG/FOOT. THE AREA GOT SORE LEADING TO IRRITATION AND SMALL AMOUNT OF BLEEDING THAT STOPPED WITH PRESSURE, SHE COMPARED TO "SKINNING HER LEG SUCH AS WITH A FALL". SHE USED A PRESCRIPTION MEDICATION CLOBETASOL PROPIONATE THAT WAS PRESCRIBED FOR A DIFFERENT INDICATION TO TREAT IT. THE CONSUMER IS A NEWER USER AND DENIED ANY VISIBLE DEFECT TO THE OUTLET STRIP. SHE STATED THAT ALL POUCHES IN THE BOX WERE AFFECTED WITH IRRITATION OCCURRING WITHIN THE FIRST DAY OF USE. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer; Skin Inflammation/ Irritation
MAUDE report 20731755 ↗MalfunctionNov 20, 2024Sharp Edges; Sharp Edges
THE END USER REPORTED THAT THE TAIL CLOSURE (SHARP CORNER EDGE OF OUTLET STRIP) CAUSED RUBBING ON THE RIGHT LEG/FOOT. THE AREA GOT SORE LEADING TO IRRITATION AND SMALL AMOUNT OF BLEEDING THAT STOPPED WITH PRESSURE, SHE COMPARED TO "SKINNING HER LEG SUCH AS WITH A FALL". SHE USED A PRESCRIPTION MEDICATION CLOBETASOL PROPIONATE THAT WAS PRESCRIBED FOR A DIFFERENT INDICATION TO TREAT IT. THE CONSUMER IS A NEWER USER AND DENIED ANY VISIBLE DEFECT TO THE OUTLET STRIP. SHE STATED THAT ALL POUCHES IN THE BOX WERE AFFECTED WITH IRRITATION OCCURRING WITHIN THE FIRST DAY OF USE. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer; Skin Inflammation/ Irritation
MAUDE report 20731754 ↗MalfunctionNov 20, 2024Sharp Edges; Sharp Edges
THE END USER REPORTED THAT THE TAIL CLOSURE (SHARP CORNER EDGE OF OUTLET STRIP) CAUSED RUBBING ON THE RIGHT LEG/FOOT. THE AREA GOT SORE LEADING TO IRRITATION AND SMALL AMOUNT OF BLEEDING THAT STOPPED WITH PRESSURE, SHE COMPARED TO "SKINNING HER LEG SUCH AS WITH A FALL". SHE USED A PRESCRIPTION MEDICATION CLOBETASOL PROPIONATE THAT WAS PRESCRIBED FOR A DIFFERENT INDICATION TO TREAT IT. THE CONSUMER IS A NEWER USER AND DENIED ANY VISIBLE DEFECT TO THE OUTLET STRIP. SHE STATED THAT ALL POUCHES IN THE BOX WERE AFFECTED WITH IRRITATION OCCURRING WITHIN THE FIRST DAY OF USE. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer; Skin Inflammation/ Irritation
MAUDE report 20731753 ↗MalfunctionNov 20, 2024Sharp Edges; Sharp Edges
THE END USER REPORTED THAT THE TAIL CLOSURE (SHARP CORNER EDGE OF OUTLET STRIP) CAUSED RUBBING ON THE RIGHT LEG/FOOT. THE AREA GOT SORE LEADING TO IRRITATION AND SMALL AMOUNT OF BLEEDING THAT STOPPED WITH PRESSURE, SHE COMPARED TO "SKINNING HER LEG SUCH AS WITH A FALL". SHE USED A PRESCRIPTION MEDICATION CLOBETASOL PROPIONATE THAT WAS PRESCRIBED FOR A DIFFERENT INDICATION TO TREAT IT. THE CONSUMER IS A NEWER USER AND DENIED ANY VISIBLE DEFECT TO THE OUTLET STRIP. SHE STATED THAT ALL POUCHES IN THE BOX WERE AFFECTED WITH IRRITATION OCCURRING WITHIN THE FIRST DAY OF USE. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer; Skin Inflammation/ Irritation
MAUDE report 20731752 ↗MalfunctionNov 20, 2024Sharp Edges; Sharp Edges
THE END USER REPORTED THAT THE TAIL CLOSURE (SHARP CORNER EDGE OF OUTLET STRIP) CAUSED RUBBING ON THE RIGHT LEG/FOOT. THE AREA GOT SORE LEADING TO IRRITATION AND SMALL AMOUNT OF BLEEDING THAT STOPPED WITH PRESSURE, SHE COMPARED TO "SKINNING HER LEG SUCH AS WITH A FALL". SHE USED A PRESCRIPTION MEDICATION CLOBETASOL PROPIONATE THAT WAS PRESCRIBED FOR A DIFFERENT INDICATION TO TREAT IT. THE CONSUMER IS A NEWER USER AND DENIED ANY VISIBLE DEFECT TO THE OUTLET STRIP. SHE STATED THAT ALL POUCHES IN THE BOX WERE AFFECTED WITH IRRITATION OCCURRING WITHIN THE FIRST DAY OF USE. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer; Skin Inflammation/ Irritation
MAUDE report 20731708 ↗MalfunctionNov 20, 2024Sharp Edges; Sharp Edges
THE END USER REPORTED THAT THE TAIL CLOSURE (SHARP CORNER EDGE OF OUTLET STRIP) CAUSED RUBBING ON THE RIGHT LEG/FOOT. THE AREA GOT SORE LEADING TO IRRITATION AND SMALL AMOUNT OF BLEEDING THAT STOPPED WITH PRESSURE, SHE COMPARED TO "SKINNING HER LEG SUCH AS WITH A FALL". SHE USED A PRESCRIPTION MEDICATION CLOBETASOL PROPIONATE THAT WAS PRESCRIBED FOR A DIFFERENT INDICATION TO TREAT IT. THE CONSUMER IS A NEWER USER AND DENIED ANY VISIBLE DEFECT TO THE OUTLET STRIP. SHE STATED THAT ALL POUCHES IN THE BOX WERE AFFECTED WITH IRRITATION OCCURRING WITHIN THE FIRST DAY OF USE. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer; Skin Inflammation/ Irritation
MAUDE report 20731707 ↗MalfunctionNov 20, 2024Sharp Edges; Sharp Edges
THE END USER REPORTED THAT THE TAIL CLOSURE (SHARP CORNER EDGE OF OUTLET STRIP) CAUSED RUBBING ON THE RIGHT LEG/FOOT. THE AREA GOT SORE LEADING TO IRRITATION AND SMALL AMOUNT OF BLEEDING THAT STOPPED WITH PRESSURE, SHE COMPARED TO "SKINNING HER LEG SUCH AS WITH A FALL". SHE USED A PRESCRIPTION MEDICATION CLOBETASOL PROPIONATE THAT WAS PRESCRIBED FOR A DIFFERENT INDICATION TO TREAT IT. THE CONSUMER IS A NEWER USER AND DENIED ANY VISIBLE DEFECT TO THE OUTLET STRIP. SHE STATED THAT ALL POUCHES IN THE BOX WERE AFFECTED WITH IRRITATION OCCURRING WITHIN THE FIRST DAY OF USE. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Abrasion; Hemorrhage/Blood Loss/Bleeding; Pressure Sore/Ulcer; Skin Inflammation/ Irritation
MAUDE report 20731706 ↗
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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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