Devices › Cutaneous tissue adhesive with mesh
Device brand name · Surgical sealant
Dermabond Prineo 22cm Skin Closure: medical device reports filed with FDA
263 reports name it, 2017–2019. Manufacturer given most often on reports: Ethicon. Product code OMD.
- 263
- device reports naming the brand
- 0% of all MAUDE reports · about 30 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 25.1%
- classified as malfunction
- 8.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
263 medical device reports received by FDA name the brand "Dermabond Prineo 22cm Skin Closure" (surgical sealant); the manufacturer given most often on reports is Ethicon; received from November 2017 to August 2019. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 injury (74.9%) and malfunction (25.1%); across all cutaneous tissue adhesive with mesh reports (product code OMD) death is recorded in 0.1% and malfunction in 8.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device markings/labelling problem (23.6%), patient-device incompatibility (9.9%) and insufficient device problem information (2.3%). The patient problems coded most often are rash, skin irritation and hypersensitivity/allergic reaction. 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 Dermabond Prineo 22cm Skin Closure was received in the five years to August 2026; the latest was received in August 2019.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,156 reports carrying product code OMD. 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 markings/labelling problema problem with the device markings or label | 62 | 23.6% | 3.4% |
| Patient-device incompatibilitythe device did not suit the patient | 26 | 9.9% | 3.6% |
| Insufficient device problem information | 6 | 2.3% | 0.8% |
| Compatibility problem | 4 | 1.5% | 0.3% |
| Tear, rip or hole in device packaging | 3 | 1.1% | 0.3% |
| Biocompatibility | 2 | 0.8% | 0.1% |
| Device expiration issue | 1 | 0.4% | 0% |
| Improper or incorrect procedure or method | 1 | 0.4% | 0.1% |
| Loss of or failure to bond | 1 | 0.4% | 0.3% |
| Material integrity problema problem with the device material | 1 | 0.4% | 0.3% |
| Unexpected therapeutic results | 1 | 0.4% | 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 |
|---|---|---|
| Rashskin rash | 75 | 28.5% |
| Skin irritationirritated skin | 71 | 27% |
| Hypersensitivity/allergic reaction | 55 | 20.9% |
| Tissue damage | 54 | 20.5% |
| Itching sensation | 34 | 12.9% |
| Erythemaskin redness | 29 | 11% |
| Not applicable | 20 | 7.6% |
| Inflammationinflammation | 10 | 3.8% |
| Painpain, site not specified | 10 | 3.8% |
| Skin discoloration | 10 | 3.8% |
| Reactiona reaction, type not specified | 8 | 3% |
| Wound dehiscencea wound reopened | 5 | 1.9% |
| Hematomaa collection of blood under the skin or in tissue | 4 | 1.5% |
| Post operative wound infection | 4 | 1.5% |
| Seromaa collection of fluid under the skin | 3 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Dermabond Prineo 22cm Skin Closure | Product code OMD | All MAUDE reports |
|---|---|---|---|
| Reports | 263 | 2,156 | 26,136,888 |
| Share of that pool | — | 12.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 74.9% | 91.6% | 36.2% |
| Classified as malfunction | 25.1% | 8.2% | 62.3% |
| Filed by the manufacturer | 100% | 97.4% | 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 OMD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Dermabond Prineo 22cm Msh Adhesive | 412 | 82 | 0% |
| Prineo Skin Closure System | 460 | 0 | 0% |
| Dermabond Prineo 22cm Msh 3 8ml Adhesive | 325 | 5 | 0% |
| Prineo Skin Closure System Unknown Product | 247 | 20 | 0.4% |
| Dermabond | 168 | 1 | 0% |
| Dermabond Unknown Product | 204 | 15 | 0.5% |
| Ethicon Mesh Unknown | 153 | 9 | 1.3% |
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 Dermabond Prineo 22cm Skin Closure reports
How many FDA reports name Dermabond Prineo 22cm Skin Closure?
263 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?
injury (74.9%) and malfunction (25.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device markings/labelling problem (23.6%), patient-device incompatibility (9.9%), insufficient device problem information (2.3%), compatibility problem (1.5%) and tear, rip or hole in device packaging (1.1%). 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 Dermabond Prineo 22cm Skin Closure 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.