NATURARecalls & reported problems across all models

We found 15 models of NATURA by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 5,161 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2018 and Sep 25, 2026 — classified as 6 injuries, 5,155 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (5,055 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NATURA problems

NATURA models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NATURA 404593

  PROTECTOR, OSTOMY
  2,403 reports
• NATURA 411802

  PROTECTOR, OSTOMY
  966 reports
• NATURA 404592

  PROTECTOR, OSTOMY
  907 reports
• NATURA 404594

  PROTECTOR, OSTOMY
  330 reports
• NATURA 411804

  PROTECTOR, OSTOMY
  245 reports
• NATURA 411803

  PROTECTOR, OSTOMY
  161 reports
• NATURA 411801

  PROTECTOR, OSTOMY
  75 reports
• NATURA 411806

  PROTECTOR, OSTOMY
  40 reports
• NATURA 411805

  PROTECTOR, OSTOMY
  12 reports
• NATURA+ 416419

  Bag, drainage, with adhesive, ostomy
  10 reports
• NATURA 411800

  PROTECTOR, OSTOMY
  5 reports
• NATURA+ 416416

  Bag, drainage, with adhesive, ostomy
  4 reports
• NATURA 411807

  PROTECTOR, OSTOMY
  1 report
• NATURA 420696

  POUCH, COLOSTOMY
  1 report
• NATURA 421458

  PROTECTOR, OSTOMY
  1 report

Recent NATURA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of (b)(6) from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895632 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895631 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of (b)(6) from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895630 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895624 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895623 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895621 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895620 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895619 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895618 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895617 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of (b)(6) from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895616 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895614 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895612 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895611 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895609 ↗

Other Convatec, Purchasing Department products

• DUODERM9 models · 7,142 reports · 1 recall
• SUR-FIT NATURA43 models · 6,207 reports · 2 recalls
• CURE CATHETER25 models · 862 reports
• GENTLECATH GLIDE9 models · 572 reports
• ESTEEM52 models · 200 reports · 7 recalls
• ACTIVELIFE21 models · 437 reports · 2 recalls
• GENTLECATH8 models · 430 reports
• ESTEEM SYNERGY9 models · 241 reports · 1 recall