Devices › Glue, surgical, arteries
Device brand name · Surgical adhesive
Bioglue Surgical Adhesive: medical device reports filed with FDA
437 reports name it, 2003–2019. Manufacturer given most often on reports: Cryolife. Product code MUQ.
- 437
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.6%
- classified as malfunction
- 1.6% across the product code
- 8%
- classified as death, as reported
- 35 reports · not verified by FDA
FDA's MAUDE database holds 437 reports that name the brand "Bioglue Surgical Adhesive" (surgical adhesive), received between February 2003 and August 2019; the manufacturer given most often on reports is Cryolife. 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 (69.6%), other (16.2%) and death (8%); across all glue, surgical, arteries reports (product code MUQ) death is recorded in 9.1% and malfunction in 1.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (29.1%), improper or incorrect procedure or method (5.7%) and device operates differently than expected (4.6%). The patient problems coded most often are pseudoaneurysm, inflammation and surgical procedure. 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 Bioglue Surgical Adhesive was received in the five years to August 2026; the latest was received in August 2019.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 495 reports carrying product code MUQ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Insufficient device problem information | 127 | 29.1% | 28.5% |
| Improper or incorrect procedure or method | 25 | 5.7% | 5.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 20 | 4.6% | 4% |
| Explanted | 17 | 3.9% | 0% |
| Failure to adhere or bond | 10 | 2.3% | 2% |
| Patient-device incompatibilitythe device did not suit the patient | 8 | 1.8% | 2% |
| Device, removal of (non-implant) | 7 | 1.6% | 0% |
| Migration or expulsion of device | 7 | 1.6% | 1.6% |
| Device remains implanted | 6 | 1.4% | 0% |
| Loss of or failure to bond | 6 | 1.4% | 1.2% |
| Material integrity problema problem with the device material | 5 | 1.1% | 1% |
| Other (for use when an appropriate device code cannot be identified) | 5 | 1.1% | 0% |
| Reactiona reaction, type not specified | 5 | 1.1% | 0% |
| Contamination | 4 | 0.9% | 0.8% |
| Leak/splashthe device leaked | 4 | 0.9% | 0.4% |
| Material disintegration | 4 | 0.9% | 0.6% |
| Product quality problem | 4 | 0.9% | 0% |
| Material fragmentation | 3 | 0.7% | 1.4% |
| Peeled/delaminated | 3 | 0.7% | 0.6% |
| Replace | 3 | 0.7% | 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) | Reports | Share |
|---|---|---|
| Pseudoaneurysm | 48 | 11% |
| Inflammationinflammation | 42 | 9.6% |
| Surgical procedure | 32 | 7.3% |
| Deaththe patient died; cause not stated by this term | 28 | 6.4% |
| Swellingswelling | 28 | 6.4% |
| Abscessa collection of pus | 21 | 4.8% |
| Impaired healingslow healing | 19 | 4.3% |
| Hospitalization required | 18 | 4.1% |
| Fever | 17 | 3.9% |
| Surgical procedure, repeated | 17 | 3.9% |
| Purulent discharge | 16 | 3.7% |
| Cerebrospinal fluid leakage | 14 | 3.2% |
| Treatment with medication(s) | 14 | 3.2% |
| Bacterial infectiona bacterial infection | 13 | 3% |
| Other (for use when an appropriate patient code cannot be identified) | 13 | 3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bioglue Surgical Adhesive | Product code MUQ | All MAUDE reports |
|---|---|---|---|
| Reports | 437 | 495 | 26,136,888 |
| Share of that pool | — | 88.3% | 0% |
| Classified as death, per 1,000 reports | 80 | 91 | 9 |
| Classified as injury | 69.6% | 84.8% | 36.2% |
| Classified as malfunction | 1.6% | 1.6% | 62.3% |
| Filed by the manufacturer | 99.8% | 98.6% | 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."
Questions about Bioglue Surgical Adhesive reports
How many FDA reports name Bioglue Surgical Adhesive?
437 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 (69.6%), other (16.2%) and death (8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (29.1%), improper or incorrect procedure or method (5.7%), device operates differently than expected (4.6%), explanted (3.9%) and failure to adhere or bond (2.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bioglue Surgical 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.