Reported Reactions

Devices › Tissue adhesive for the topical approximation of skin

Device brand name · Adhesive topical skin

Dermabond Advanced 0 7ml - 12ea: medical device reports filed with FDA

557 reports name it, 2019–2026. Manufacturer given most often on reports: Ethicon. Product code MPN.

557
device reports naming the brand
0% of all MAUDE reports · about 80 a year
59
reports, 12 months to August 2026
132 in the 12 months before
36.4%
classified as malfunction
34.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

557 medical device reports received by FDA name the brand "Dermabond Advanced 0 7ml - 12ea" (adhesive topical skin); the manufacturer given most often on reports is Ethicon; received from July 2019 to June 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

59 reports arrived in the 12 months to August 2026, down 55% from 132 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 (63.6%) and malfunction (36.4%); 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 patient device interaction problem (16.7%), device contaminated during manufacture or shipping (11.3%) and break (5.6%). The patient problems coded most often are skin inflammation/ irritation, rash and erythema. 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

01428Sep 2021: 3Oct 2021: 6Nov 2021: 3Dec 2021: 22022Jan 2022: 4Feb 2022: 2Mar 2022: 2Apr 2022: 14May 2022: 17Jun 2022: 9Jul 2022: 19Aug 2022: 7Sep 2022: 2Oct 2022: 4Nov 2022: 1Dec 2022: 52023Jan 2023: 1Feb 2023: 3Mar 2023: 9Apr 2023: 3May 2023: 0Jun 2023: 10Jul 2023: 1Aug 2023: 3Sep 2023: 3Oct 2023: 5Nov 2023: 17Dec 2023: 52024Jan 2024: 6Feb 2024: 5Mar 2024: 9Apr 2024: 22May 2024: 4Jun 2024: 9Jul 2024: 23Aug 2024: 3Sep 2024: 6Oct 2024: 2Nov 2024: 2Dec 2024: 272025Jan 2025: 4Feb 2025: 21Mar 2025: 3Apr 2025: 11May 2025: 8Jun 2025: 9Jul 2025: 11Aug 2025: 28Sep 2025: 13Oct 2025: 19Nov 2025: 8Dec 2025: 42026Jan 2026: 8Feb 2026: 3Mar 2026: 0Apr 2026: 3May 2026: 0Jun 2026: 1Jul 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

0701392019: 4120192020: 6320202021: 3520212022: 8620222023: 6020232024: 11820242025: 13920252026: 152026

Event type and report source

Event type, as classified on the report

Death0%0
Injury63.6%354
Malfunction36.4%203
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%557
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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
Patient device interaction problem9316.7%4.4%
Device contaminated during manufacture or shipping6311.3%2.2%
Breakthe device broke315.6%7.4%
Material integrity problema problem with the device material40.7%2.4%
Delivered as unsterile product30.5%0.3%
Device contamination with chemical or other material30.5%0.1%
Device markings/labelling problema problem with the device markings or label30.5%0.2%
Packaging problem30.5%0.7%
Activation problem20.4%0.1%
Contamination /decontamination problem10.2%0.1%
Loss of or failure to bond10.2%0.5%
Material discolored10.2%0.1%
Material separation10.2%0.2%

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
Skin inflammation/ irritation18132.5%
Rashskin rash8014.4%
Erythemaskin redness7914.2%
Hypersensitivity/allergic reaction549.7%
Itching sensation509%
Blistera blister376.6%
Skin irritationirritated skin285%
Inflammationinflammation254.5%
Swelling/ edema244.3%
Tissue damage173.1%
Local reaction152.7%
Not applicable152.7%
Painpain, site not specified112%
Fluid discharge101.8%
Swellingswelling81.4%

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

In context

MeasureDermabond Advanced 0 7ml - 12eaProduct code MPNAll MAUDE reports
Reports5573,64626,136,888
Share of that pool—15.3%0%
Classified as death, per 1,000 reports029
Classified as injury63.6%54.9%36.2%
Classified as malfunction36.4%34.1%62.3%
Filed by the manufacturer100%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 Topical Skin Adhesive47600.4%
Dermabond Advanced Topical Skin Adhesive37100%
Histoacryl Blue 0 5ml28000%
Dermabond Unknown Product204150.5%
DermaBond Advanced179540%
Liquiband Exceed15880%
Dermabond16810%
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 Advanced 0 7ml - 12ea reports

How many FDA reports name Dermabond Advanced 0 7ml - 12ea?

557 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 59 in the latest 12 months.

What kinds of events are reported?

injury (63.6%) and malfunction (36.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

patient device interaction problem (16.7%), device contaminated during manufacture or shipping (11.3%), break (5.6%), material integrity problem (0.7%) and delivered as unsterile product (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 Dermabond Advanced 0 7ml - 12ea 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.