Devices › Tissue adhesive for the topical approximation of skin
Device brand name · Tissue adhesive for soft tissue approximation
Dermabond Topical Skin Adhesive: medical device reports filed with FDA
476 reports name it, 1999–2018. Manufacturer given most often on reports: Closure Medical. Product code MPN.
- 476
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 7.1%
- classified as malfunction
- 34.1% across the product code
- 0.4%
- classified as death, as reported
- 2 reports · not verified by FDA
476 medical device reports received by FDA name the brand "Dermabond Topical Skin Adhesive" (tissue adhesive for soft tissue approximation); the manufacturer given most often on reports is Closure Medical; received from February 1999 to December 2018. 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 other (66%), injury (26.5%) and malfunction (7.1%); across all tissue adhesive for the topical approximation of skin reports (product code MPN) death is recorded in 0.2% and malfunction in 34.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are misapplication (22.5%), other (for use when an appropriate device code cannot be identified) (8.4%) and migration or expulsion of device (6.3%). The patient problems coded most often are therapy/non-surgical treatment, additional, treatment with medication(s) and wound dehiscence. 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 Topical Skin Adhesive was received in the five years to August 2026; the latest was received in December 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,646 reports carrying product code MPN. 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 |
|---|---|---|---|
| Misapplication | 107 | 22.5% | 3.1% |
| Other (for use when an appropriate device code cannot be identified) | 40 | 8.4% | 9% |
| Migration or expulsion of device | 30 | 6.3% | 0.9% |
| Reactiona reaction, type not specified | 17 | 3.6% | 9.4% |
| Replace | 16 | 3.4% | 0.6% |
| Sticking | 11 | 2.3% | 0.3% |
| Breakthe device broke | 10 | 2.1% | 7.4% |
| Device issuea problem with the device | 10 | 2.1% | 0.3% |
| Device, removal of (non-implant) | 9 | 1.9% | 0.4% |
| Explanted | 8 | 1.7% | 0.3% |
| Patient-device incompatibilitythe device did not suit the patient | 7 | 1.5% | 3.9% |
| Improper or incorrect procedure or method | 5 | 1.1% | 0.5% |
| Insufficient device problem information | 5 | 1.1% | 2.5% |
| Loss of or failure to bond | 5 | 1.1% | 0.5% |
| Spillage, accidental | 5 | 1.1% | 0.1% |
| Difficult to removethe device was hard to remove | 3 | 0.6% | 0.1% |
| Failure to adhere or bond | 3 | 0.6% | 0.6% |
| Leak/splashthe device leaked | 3 | 0.6% | 0.8% |
| Implant, removal of | 2 | 0.4% | 0.1% |
| Malposition of device | 2 | 0.4% | 0.1% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, additional | 154 | 32.4% |
| Treatment with medication(s) | 148 | 31.1% |
| Wound dehiscencea wound reopened | 67 | 14.1% |
| Other (for use when an appropriate patient code cannot be identified) | 61 | 12.8% |
| Eye injury | 44 | 9.2% |
| Erythemaskin redness | 40 | 8.4% |
| Hospitalization required | 28 | 5.9% |
| Surgical procedure | 28 | 5.9% |
| Rashskin rash | 26 | 5.5% |
| Itching sensation | 21 | 4.4% |
| Abscessa collection of pus | 17 | 3.6% |
| Not applicable | 17 | 3.6% |
| Blister(s) | 14 | 2.9% |
| Drainage | 13 | 2.7% |
| Painpain, site not specified | 13 | 2.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Dermabond Topical Skin Adhesive | Product code MPN | All MAUDE reports |
|---|---|---|---|
| Reports | 476 | 3,646 | 26,136,888 |
| Share of that pool | — | 13.1% | 0% |
| Classified as death, per 1,000 reports | 4 | 2 | 9 |
| Classified as injury | 26.5% | 54.9% | 36.2% |
| Classified as malfunction | 7.1% | 34.1% | 62.3% |
| Filed by the manufacturer | 99.6% | 94.5% | 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 MPN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Dermabond Advanced 0 7ml - 12ea | 557 | 59 | 0% |
| Dermabond Advanced Topical Skin Adhesive | 371 | 0 | 0% |
| Histoacryl Blue 0 5ml | 280 | 0 | 0% |
| Dermabond Unknown Product | 204 | 15 | 0.5% |
| DermaBond Advanced | 179 | 54 | 0% |
| Liquiband Exceed | 158 | 8 | 0% |
| Dermabond | 168 | 1 | 0% |
| Prineo Skin Closure System | 460 | 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 Dermabond Topical Skin Adhesive reports
How many FDA reports name Dermabond Topical Skin Adhesive?
476 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?
other (66%), injury (26.5%) and malfunction (7.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
misapplication (22.5%), other (for use when an appropriate device code cannot be identified) (8.4%), migration or expulsion of device (6.3%), reaction (3.6%) and replace (3.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Dermabond Topical Skin Adhesive 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.