Reported Reactions

Devices › Protector, ostomy

Device brand name · Protector ostomy

Natura: medical device reports filed with FDA

27,007 reports name it, 2017–2026. Manufacturer given most often on reports: Convatec Dominican Republic. Product code EXE.

27,007
device reports naming the brand
0.1% of all MAUDE reports · about 2,871 a year
158
reports, 12 months to August 2026
341 in the 12 months before
99.4%
classified as malfunction
93.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

27,007 medical device reports received by FDA name the brand "Natura" (protector ostomy); the manufacturer given most often on reports is Convatec Dominican Republic; received from February 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

158 reports arrived in the 12 months to August 2026, down 54% from 341 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (99.4%) and injury (0.6%); across all protector, ostomy reports (product code EXE) death is recorded in 0% and malfunction in 93.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are malposition of device (97.9%), positioning problem (5.8%) and fluid/blood leak (2.2%). The patient problems coded most often are no patient involvement, skin irritation and tissue damage. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

075149Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 1Aug 2022: 21Sep 2022: 36Oct 2022: 5Nov 2022: 35Dec 2022: 122023Jan 2023: 56Feb 2023: 17Mar 2023: 7Apr 2023: 37May 2023: 72Jun 2023: 4Jul 2023: 16Aug 2023: 93Sep 2023: 13Oct 2023: 3Nov 2023: 12Dec 2023: 322024Jan 2024: 20Feb 2024: 71Mar 2024: 41Apr 2024: 28May 2024: 19Jun 2024: 3Jul 2024: 33Aug 2024: 15Sep 2024: 15Oct 2024: 11Nov 2024: 24Dec 2024: 352025Jan 2025: 20Feb 2025: 149Mar 2025: 7Apr 2025: 20May 2025: 15Jun 2025: 13Jul 2025: 24Aug 2025: 8Sep 2025: 4Oct 2025: 20Nov 2025: 10Dec 2025: 182026Jan 2026: 5Feb 2026: 7Mar 2026: 0Apr 2026: 15May 2026: 43Jun 2026: 22Jul 2026: 1Aug 2026: 13

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

07,94815,8962017: 2520172018: 1,81520182019: 15,89620192020: 8,07020202022: 11020222023: 36220232024: 31520242025: 30820252026: 1062026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.6%152
Malfunction99.4%26,853
Other0%2
Not given0%0

Who filed the report

Manufacturer report100%27,007
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 32,273 reports carrying product code EXE. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Malposition of device26,43297.9%91.4%
Positioning problem1,5725.8%5.9%
Fluid/blood leak5952.2%2.5%
Sharp edges1680.6%0.3%
Material disintegration1280.5%0.7%
Material too rigid or stiff1200.4%0.8%
Material erosion560.2%0.2%
Positioning failure280.1%0.2%
Melted270.1%0.1%
Material separation250.1%0.1%
Material split, cut or torn200.1%0.1%
Partial blockage200.1%0.1%
Complete blockage190.1%0.1%
Improper or incorrect procedure or method170.1%0.1%
Material protrusion/extrusion150.1%0.1%
Obstruction of flow120%0%
Device handling problem90%0.1%
Device damaged prior to usethe device was damaged before use60%0%
Off-label use60%0%
Activation, positioning or separation problem40%0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
No patient involvement10,40938.5%
Skin irritationirritated skin3171.2%
Tissue damage2851.1%
Blood loss2540.9%
Abrasion1340.5%
Tissue breakdown1270.5%
Painpain, site not specified1110.4%
Discomfortdiscomfort950.4%
Laceration(s)890.3%
Erythemaskin redness770.3%
Hemorrhage/blood loss/bleeding770.3%
Rashskin rash500.2%
Itching sensation470.2%
Obstruction/occlusion370.1%
Fungal infectiona fungal infection310.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureNaturaProduct code EXEAll MAUDE reports
Reports27,00732,27326,136,888
Share of that pool—83.7%0.1%
Classified as death, per 1,000 reports009
Classified as injury0.6%6.2%36.2%
Classified as malfunction99.4%93.7%62.3%
Filed by the manufacturer100%99.9%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code EXE

BrandReportsLatest 12 monthsClassified as death
L3o0200 - Natura1,61700%
Sur-Fit Natura4911670%
Accordion Flange44200%
Esteem Synergy27200%
Duoderm10,7585,5270%
Extraction Bag For Mis21290%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Natura reports

How many FDA reports name Natura?

27,007 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 158 in the latest 12 months.

What kinds of events are reported?

malfunction (99.4%) and injury (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

malposition of device (97.9%), positioning problem (5.8%), fluid/blood leak (2.2%), sharp edges (0.6%) and material disintegration (0.5%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Natura was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.