Reported Reactions

Devices › Tissue adhesive for the topical approximation of skin

Device brand name · Topical skin adhesive

Dermabond: medical device reports filed with FDA

168 reports name it, 2003–2025. Manufacturer given most often on reports: Ethicon. Product code MPN.

168
device reports naming the brand
0% of all MAUDE reports · about 7 a year
1
reports, 12 months to August 2026
5 in the 12 months before
6.5%
classified as malfunction
34.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 168 reports that name the brand "Dermabond" (topical skin adhesive), received between August 2003 and December 2025; the manufacturer given most often on reports is Ethicon. Spellings of one product vary from report to report.

1 reports arrived in the 12 months to August 2026, down 80% from 5 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 (93.5%) and malfunction (6.5%); 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 reaction (28.6%), other (for use when an appropriate device code cannot be identified) (14.9%) and insufficient device problem information (2.4%). The patient problems coded most often are treatment with medication(s), reaction and rash. 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

024Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 1Sep 2022: 1Oct 2022: 0Nov 2022: 0Dec 2022: 12023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 1Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 1Jul 2024: 4Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 32025Jan 2025: 0Feb 2025: 0Mar 2025: 1Apr 2025: 1May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 12026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

032632003: 1120032009: 32010: 520102013: 112014: 6320142015: 262016: 1220162017: 222022: 320222024: 92025: 32025

Event type and report source

Event type, as classified on the report

Death0%0
Injury93.5%157
Malfunction6.5%11
Other0%0
Not given0%0

Who filed the report

Manufacturer report75%126
Voluntary report22.6%38
User facility report0%0
Distributor report0%0
Not given2.4%4

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)ReportsShareShare across product code
Reactiona reaction, type not specified4828.6%9.4%
Other (for use when an appropriate device code cannot be identified)2514.9%9%
Insufficient device problem information42.4%2.5%
Patient-device incompatibilitythe device did not suit the patient42.4%3.9%
Breakthe device broke21.2%7.4%
Contamination10.6%0.1%
Device operates differently than expectedthe device behaved unexpectedly10.6%1%
Material perforation10.6%0.1%
Positioning failure10.6%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
Treatment with medication(s)4325.6%
Reactiona reaction, type not specified4225%
Rashskin rash3319.6%
Inflammationinflammation2112.5%
Hypersensitivity/allergic reaction1810.7%
Surgical procedure169.5%
Allergic reactionan allergic reaction158.9%
Extrusion116.5%
Itching sensation116.5%
Painpain, site not specified106%
Erythemaskin redness95.4%
Blister(s)84.8%
Granuloma84.8%
Therapy/non-surgical treatment, additional84.8%
Impaired healingslow healing74.2%

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

In context

MeasureDermabondProduct code MPNAll MAUDE reports
Reports1683,64626,136,888
Share of that pool—4.6%0%
Classified as death, per 1,000 reports029
Classified as injury93.5%54.9%36.2%
Classified as malfunction6.5%34.1%62.3%
Filed by the manufacturer75%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

BrandReportsLatest 12 monthsClassified as death
Dermabond Advanced 0 7ml - 12ea557590%
Dermabond Topical Skin Adhesive47600.4%
Dermabond Advanced Topical Skin Adhesive37100%
Histoacryl Blue 0 5ml28000%
Dermabond Unknown Product204150.5%
DermaBond Advanced179540%
Liquiband Exceed15880%
Prineo Skin Closure System46000%

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 reports

How many FDA reports name Dermabond?

168 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.

What kinds of events are reported?

injury (93.5%) and malfunction (6.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

reaction (28.6%), other (for use when an appropriate device code cannot be identified) (14.9%), insufficient device problem information (2.4%), patient-device incompatibility (2.4%) and break (1.2%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (75%) and voluntary reports (22.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Dermabond 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.