Devices › Dressing, wound, occlusive
Device brand name · Dressing wound occlusive
Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing: medical device reports filed with FDA
6,205 reports name it, 2014–2020. Manufacturer given most often on reports: Convatec Dominican Republic. Product code NAD.
- 6,205
- device reports naming the brand
- 0% of all MAUDE reports · about 521 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.8%
- classified as malfunction
- 95.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 6,205 reports that name the brand "Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing" (dressing wound occlusive), received between August 2014 and December 2020; the manufacturer given most often on reports is Convatec Dominican Republic. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (99.8%) and injury (0.2%); across all dressing, wound, occlusive reports (product code NAD) death is recorded in 0% and malfunction in 95.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device contamination with chemical or other material (91.1%), delivered as unsterile product (16.2%) and unsealed device packaging (5.9%). The patient problems coded most often are no patient involvement, tissue damage and skin discoloration. 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
No report naming Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing was received in the five years to August 2026; the latest was received in December 2020.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 18,954 reports carrying product code NAD. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device contamination with chemical or other material | 5,654 | 91.1% | 30.5% |
| Delivered as unsterile product | 1,005 | 16.2% | 59.7% |
| Unsealed device packaging | 368 | 5.9% | 4.3% |
| Difficult to removethe device was hard to remove | 110 | 1.8% | 2.1% |
| Device contaminated during manufacture or shipping | 79 | 1.3% | 0.9% |
| Packaging problem | 36 | 0.6% | 2.7% |
| Difficult to open or remove packaging material | 20 | 0.3% | 0.1% |
| Product quality problem | 12 | 0.2% | 0.1% |
| Failure to adhere or bond | 10 | 0.2% | 0.4% |
| Tear, rip or hole in device packaging | 7 | 0.1% | 2.1% |
| Contamination /decontamination problem | 4 | 0.1% | 51.3% |
| Nonstandard device | 4 | 0.1% | 0.7% |
| Material disintegration | 3 | 0% | 0.7% |
| Device handling problem | 2 | 0% | 0% |
| Device packaging compromised | 2 | 0% | 0.1% |
| Delamination | 1 | 0% | 0% |
| Device expiration issue | 1 | 0% | 0% |
| Hole in material | 1 | 0% | 0% |
| Loss of or failure to bond | 1 | 0% | 0.9% |
| Material deformation | 1 | 0% | 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) | Reports | Share |
|---|---|---|
| No patient involvement | 6,060 | 97.7% |
| Tissue damage | 24 | 0.4% |
| Skin discoloration | 10 | 0.2% |
| Skin irritationirritated skin | 9 | 0.1% |
| Scar tissue | 7 | 0.1% |
| Hypersensitivity/allergic reaction | 2 | 0% |
| Itching sensation | 2 | 0% |
| Wheal(s) | 2 | 0% |
| Bacterial infectiona bacterial infection | 1 | 0% |
| Burning sensationa burning feeling | 1 | 0% |
| Discomfortdiscomfort | 1 | 0% |
| Exposure to body fluids | 1 | 0% |
| Inflammationinflammation | 1 | 0% |
| Irritationirritation | 1 | 0% |
| Necrosisdeath of tissue | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing | Product code NAD | All MAUDE reports |
|---|---|---|---|
| Reports | 6,205 | 18,954 | 26,136,888 |
| Share of that pool | — | 32.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.2% | 4.8% | 36.2% |
| Classified as malfunction | 99.8% | 95.1% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 NAD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Duoderm | 10,758 | 5,527 | 0% |
| L3w0750 - Duoderm | 293 | 0 | 0% |
| Aquacel Foam | 489 | 124 | 0% |
| Equate | 317 | 37 | 0.3% |
| Iv3000 1 Hand 6x7cm Ctn 100 | 157 | 3 | 0% |
| Opsite Flexifix Gentle 5cmx5m | 206 | 0 | 0% |
| EnCor Biopsy Probe | 5,264 | 15 | 0% |
| Renasys Go Npwt Device | 201 | 0 | 0% |
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 Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing reports
How many FDA reports name Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing?
6,205 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (99.8%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device contamination with chemical or other material (91.1%), delivered as unsterile product (16.2%), unsealed device packaging (5.9%), difficult to remove (1.8%) and device contaminated during manufacture or shipping (1.3%). 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 Duoderm/Granuflex/Duoactive - Moisture Retentive Duoderm Cgf Dressing 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.