Tissue adhesive for the topical approximation of skin: medical device reports filed with FDA

3,646 reports carry this product code, 1999–2026; 9 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

3,646
reports with this product code: 0% of all MAUDE reports; 236
reports, 12 months to August 2026: 241 in the 12 months before; 34.1%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code MPN is FDA's classification for "Tissue adhesive for the topical approximation of skin" (general, Plastic Surgery panel), a class 2 device. 3,646 medical device reports carry this product code, 0% of the MAUDE database, from February 1999 to August 2026.

236 reports arrived in the 12 months to August 2026, close to the 241 of 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 (54.9%), malfunction (34.1%) and other (10.1%). 9 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Dermabond Advanced 0 7ml - 12ea	557	59	0%	36.4%
Dermabond Topical Skin Adhesive	476	0	0.4%	7.1%
Dermabond Advanced Topical Skin Adhesive	371	0	0%	40.4%
Histoacryl Blue 0 5ml	277	0	0%	99.6%
Dermabond Unknown Product	193	15	0.5%	2.9%
DermaBond Advanced	179	54	0%	25.1%
Liquiband Exceed	158	8	0%	1.3%
Dermabond	149	1	0%	6.5%
Prineo Skin Closure System	49	0	0%	2.4%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Ethicon	763	20.9%
B Braun Surgical	534	14.6%
Cryolife	11	0.3%
Ethicon Endo Surgery Cincinnati	7	0.2%
United States Surgical	4	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.2%7

Injury54.9%2,003

Malfunction34.1%1,244

Other10.1%370

Not given0.6%22

Who filed

Manufacturer report94.5%3,446

Voluntary report3.7%134

User facility report0%0

Distributor report0.3%10

Not given1.5%56

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Reactiona reaction, type not specified	343	9.4%
Other (for use when an appropriate device code cannot be identified)	328	9%
Breakthe device broke	269	7.4%
Fluid/blood leak	204	5.6%
Patient device interaction problem	161	4.4%
Patient-device incompatibilitythe device did not suit the patient	143	3.9%
Misapplication	112	3.1%
Mechanical problema mechanical problem	96	2.6%
Insufficient device problem information	90	2.5%
Material integrity problema problem with the device material	89	2.4%
Device contaminated during manufacture or shipping	82	2.2%
Gel leak	64	1.8%
Crackthe device cracked	59	1.6%
Partial blockage	38	1%
Device operates differently than expectedthe device behaved unexpectedly	37	1%
Migration or expulsion of device	33	0.9%
Leak/splashthe device leaked	28	0.8%
Packaging problem	24	0.7%
Failure to adhere or bond	21	0.6%
Replace	21	0.6%

Questions about tissue adhesive for the topical approximation of skin reports

What is product code MPN?

FDA's classification code for "Tissue adhesive for the topical approximation of skin", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,646 reports through August 2026, 236 of them in the latest 12 months.

Which brands appear most often?

Dermabond Advanced 0 7ml - 12ea (557), Dermabond Topical Skin Adhesive (476), Dermabond Advanced Topical Skin Adhesive (371), Histoacryl Blue 0 5ml (277) and Dermabond Unknown Product (193). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.