Reported Reactions

Devices › Tissue adhesive for the topical approximation of skin

Device brand name · Adhesive topical skin

Dermabond Advanced Topical Skin Adhesive: medical device reports filed with FDA

371 reports name it, 2013–2017. Manufacturer given most often on reports: Ethicon. Product code MPN.

371
device reports naming the brand
0% of all MAUDE reports · about 28 a year
0
reports, 12 months to August 2026
0 in the 12 months before
40.4%
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 371 reports that name the brand "Dermabond Advanced Topical Skin Adhesive" (adhesive topical skin), received between June 2013 and September 2017; the manufacturer given most often on reports is Ethicon. 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 injury (59.6%) and malfunction (40.4%); 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 other (for use when an appropriate device code cannot be identified) (33.2%), reaction (27%) and break (13.2%). The patient problems coded most often are reaction, treatment with medication(s) and therapy/non-surgical treatment, additional. 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 Advanced Topical Skin Adhesive was received in the five years to August 2026; the latest was received in September 2017.

By year received

049982013: 8020132014: 7820142015: 9820152016: 6320162017: 522017

Event type and report source

Event type, as classified on the report

Death0%0
Injury59.6%221
Malfunction40.4%150
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%371
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
Other (for use when an appropriate device code cannot be identified)12333.2%9%
Reactiona reaction, type not specified10027%9.4%
Breakthe device broke4913.2%7.4%
Failure to adhere or bond30.8%0.6%
Thermal decomposition of device20.5%0%
Hole in material10.3%0%
Patient-device incompatibilitythe device did not suit the patient10.3%3.9%
Unsealed device packaging10.3%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
Reactiona reaction, type not specified13335.8%
Treatment with medication(s)9124.5%
Therapy/non-surgical treatment, additional4913.2%
Wound dehiscencea wound reopened287.5%
Inflammationinflammation267%
Erythemaskin redness225.9%
Other (for use when an appropriate patient code cannot be identified)225.9%
Itching sensation174.6%
Burning sensationa burning feeling154%
Abscessa collection of pus133.5%
Allergic reactionan allergic reaction123.2%
Blister(s)123.2%
Painpain, site not specified92.4%
Surgical procedure92.4%
Cellulitisa skin infection82.2%

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

In context

MeasureDermabond Advanced Topical Skin AdhesiveProduct code MPNAll MAUDE reports
Reports3713,64626,136,888
Share of that pool—10.2%0%
Classified as death, per 1,000 reports029
Classified as injury59.6%54.9%36.2%
Classified as malfunction40.4%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 Advanced 0 7ml - 12ea557590%
Dermabond Topical Skin Adhesive47600.4%
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 Topical Skin Adhesive reports

How many FDA reports name Dermabond Advanced Topical Skin Adhesive?

371 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 (59.6%) and malfunction (40.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

other (for use when an appropriate device code cannot be identified) (33.2%), reaction (27%), break (13.2%), failure to adhere or bond (0.8%) and thermal decomposition of device (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 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.