Device brand name · Suture absorbable
Suture Unknown: medical device reports filed with FDA
469 reports name it, 2013–2026. Manufacturer given most often on reports: Ethicon.
- 469
- device reports naming the brand
- 0% of all MAUDE reports · about 37 a year
- 39
- reports, 12 months to August 2026
- 62 in the 12 months before
- 50.1%
- classified as malfunction
- 62.3% across all reports
- 0.6%
- classified as death, as reported
- 3 reports · not verified by FDA
469 medical device reports received by FDA name the brand "Suture Unknown" (suture absorbable); the manufacturer given most often on reports is Ethicon; received from September 2013 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
39 reports arrived in the 12 months to August 2026, down 37% from 62 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 malfunction (50.1%), injury (49.3%) and death (0.6%). Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (33.3%), material separation (10.2%) and detachment of device component (5.5%). The patient problems coded most often are pain, wound dehiscence and not applicable. 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Breakthe device broke | 156 | 33.3% |
| Material separation | 48 | 10.2% |
| Detachment of device component | 26 | 5.5% |
| Other (for use when an appropriate device code cannot be identified) | 23 | 4.9% |
| Material integrity problema problem with the device material | 20 | 4.3% |
| Material frayed | 7 | 1.5% |
| Needle, separation | 6 | 1.3% |
| Material discolored | 4 | 0.9% |
| Migration or expulsion of device | 4 | 0.9% |
| Reactiona reaction, type not specified | 4 | 0.9% |
| Defective component | 2 | 0.4% |
| Delivered as unsterile product | 2 | 0.4% |
| Device contaminated during manufacture or shipping | 2 | 0.4% |
| Implant extrusion | 2 | 0.4% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.2% |
| Insufficient device problem information | 1 | 0.2% |
| Loss of or failure to bond | 1 | 0.2% |
| Material erosion | 1 | 0.2% |
| Material protrusion/extrusion | 1 | 0.2% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 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) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 35 | 7.5% |
| Wound dehiscencea wound reopened | 31 | 6.6% |
| Not applicable | 22 | 4.7% |
| Hemorrhage/blood loss/bleeding | 18 | 3.8% |
| Inflammationinflammation | 18 | 3.8% |
| Pocket erosion | 14 | 3% |
| Erythemaskin redness | 13 | 2.8% |
| Foreign body in patientpart of a device left in the patient | 13 | 2.8% |
| Impaired healingslow healing | 12 | 2.6% |
| Scar tissue | 12 | 2.6% |
| Abscessa collection of pus | 10 | 2.1% |
| Hypersensitivity/allergic reaction | 10 | 2.1% |
| Post operative wound infection | 10 | 2.1% |
| Nonresorbable materials, unretrieved in body | 8 | 1.7% |
| Swelling/ edema | 8 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Suture Unknown | All MAUDE reports |
|---|---|---|
| Reports | 469 | 26,136,888 |
| Share of that pool | — | 0% |
| Classified as death, per 1,000 reports | 6 | 9 |
| Classified as injury | 49.3% | 36.2% |
| Classified as malfunction | 50.1% | 62.3% |
| Filed by the manufacturer | 100% | 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 Suture Unknown reports
How many FDA reports name Suture Unknown?
469 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 39 in the latest 12 months.
What kinds of events are reported?
malfunction (50.1%), injury (49.3%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (33.3%), material separation (10.2%), detachment of device component (5.5%), other (for use when an appropriate device code cannot be identified) (4.9%) and material integrity problem (4.3%). 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 Suture Unknown 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.