Cutaneous tissue adhesive with mesh: medical device reports filed with FDA

2,156 reports carry this product code, 2012–2026; 8 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.

2,156
reports with this product code: 0% of all MAUDE reports; 253
reports, 12 months to August 2026: 274 in the 12 months before; 8.2%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code OMD is FDA's classification for "Cutaneous tissue adhesive with mesh" (general, Plastic Surgery panel), a class 2 device. 2,156 medical device reports carry this product code, 0% of the MAUDE database, from June 2012 to August 2026.

253 reports arrived in the 12 months to August 2026, close to the 274 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 (91.6%), malfunction (8.2%) and death (0.1%). 8 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 Prineo 22cm Msh Adhesive	412	82	0%	6.1%
Prineo Skin Closure System	411	0	0%	2.4%
Dermabond Prineo 22cm Msh 3 8ml Adhesive	325	5	0%	2.2%
Dermabond Prineo 22cm Skin Closure	263	0	0%	25.1%
Prineo Skin Closure System Unknown Product	247	20	0.4%	0.4%
Dermabond	8	1	0%	6.5%
Dermabond Unknown Product	1	15	0.5%	2.9%
Ethicon Mesh Unknown	1	9	1.3%	2%

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	1,497	69.4%
Ethicon Endo Surgery Cincinnati	1	0%

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

Death0.1%2

Injury91.6%1,975

Malfunction8.2%177

Other0%0

Not given0.1%2

Who filed

Manufacturer report97.4%2,100

Voluntary report2.2%47

User facility report0%0

Distributor report0%1

Not given0.4%8

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

Device problems coded

Device problem (FDA code)	Reports	Share
Patient-device incompatibilitythe device did not suit the patient	78	3.6%
Reactiona reaction, type not specified	75	3.5%
Device markings/labelling problema problem with the device markings or label	73	3.4%
Other (for use when an appropriate device code cannot be identified)	71	3.3%
Device contaminated during manufacture or shipping	40	1.9%
Delivered as unsterile product	17	0.8%
Insufficient device problem information	17	0.8%
Material separation	12	0.6%
Compatibility problem	7	0.3%
Tear, rip or hole in device packaging	7	0.3%
Loss of or failure to bond	6	0.3%
Material integrity problema problem with the device material	6	0.3%
Patient device interaction problem	6	0.3%
Coagulation in device or device ingredient	4	0.2%
Contamination /decontamination problem	3	0.1%
Improper or incorrect procedure or method	3	0.1%
Incorrect, inadequate or imprecise result or readings	3	0.1%
Lack of effect	3	0.1%
Biocompatibility	2	0.1%
Component missing	2	0.1%

Questions about cutaneous tissue adhesive with mesh reports

What is product code OMD?

FDA's classification code for "Cutaneous tissue adhesive with mesh", 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?

2,156 reports through August 2026, 253 of them in the latest 12 months.

Which brands appear most often?

Dermabond Prineo 22cm Msh Adhesive (412), Prineo Skin Closure System (411), Dermabond Prineo 22cm Msh 3 8ml Adhesive (325), Dermabond Prineo 22cm Skin Closure (263) and Prineo Skin Closure System Unknown Product (247). 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.