Devices › Suture, surgical, absorbable, polydioxanone
Device brand name · Suture surgical absorbable
Pds: medical device reports filed with FDA
211 reports name it, 2013–2026. Manufacturer given most often on reports: Ethicon. Product code NEW.
- 211
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 199
- reports, 12 months to August 2026
- 0 in the 12 months before
- 87.2%
- classified as malfunction
- 76.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
211 medical device reports received by FDA name the brand "Pds" (suture surgical absorbable); the manufacturer given most often on reports is Ethicon; received from April 2013 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
199 reports arrived in the 12 months to August 2026, with 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 malfunction (87.2%) and injury (12.8%); across all suture, surgical, absorbable, polydioxanone reports (product code NEW) death is recorded in 0.3% and malfunction in 76.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (61.1%), material separation (23.7%) and component misassembled (2.4%). The patient problems coded most often are impaired healing, wound dehiscence and foreign body in patient. 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 16,088 reports carrying product code NEW. 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 |
|---|---|---|---|
| Breakthe device broke | 129 | 61.1% | 50.7% |
| Material separation | 50 | 23.7% | 19.8% |
| Component misassembled | 5 | 2.4% | 0.3% |
| Device contaminated during manufacture or shipping | 2 | 0.9% | 0.3% |
| Device markings/labelling problema problem with the device markings or label | 2 | 0.9% | 0.5% |
| Failure to degrade | 2 | 0.9% | 0.1% |
| Material integrity problema problem with the device material | 2 | 0.9% | 2.4% |
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 |
|---|---|---|
| Impaired healingslow healing | 11 | 5.2% |
| Wound dehiscencea wound reopened | 6 | 2.8% |
| Foreign body in patientpart of a device left in the patient | 4 | 1.9% |
| Hernia | 3 | 1.4% |
| Swelling/ edema | 2 | 0.9% |
| Adult respiratory distress syndrome | 1 | 0.5% |
| Atelectasis | 1 | 0.5% |
| Blistera blister | 1 | 0.5% |
| Dyspneashortness of breath | 1 | 0.5% |
| Granuloma | 1 | 0.5% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.5% |
| Hemorrhage/blood loss/bleeding | 1 | 0.5% |
| Incontinence | 1 | 0.5% |
| Inflammationinflammation | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pds | Product code NEW | All MAUDE reports |
|---|---|---|---|
| Reports | 211 | 16,088 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 12.8% | 21.2% | 36.2% |
| Classified as malfunction | 87.2% | 76.8% | 62.3% |
| Filed by the manufacturer | 95.7% | 99.4% | 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 NEW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Stratafix | 925 | 647 | 0.1% |
| Sfx Sym Pds+ Uni Vio 18in 1 S/A Ct | 427 | 0 | 0% |
| Sfx Sym Pds+ Uni Vio 18in 1 S/A Ctb-1 | 343 | 0 | 0% |
| Sfx Sym Pds+ Uni Vio 18in 1 S/A Ctx | 308 | 0 | 0% |
| Sfx Sym Pds+ Uni Vio 18in 0 S/A Ct-1 | 302 | 0 | 0% |
| Stratafix Symmetric Pds Plus Knotless Tissue Control Device | 270 | 0 | 0% |
| Sfxspi Pds+ Bi Vio 14in2 1 Da Ctx | 260 | 0 | 0% |
| Sfx Sym Pds+ Uni Vio 18in 1 S/A Ct-1 | 220 | 0 | 0.5% |
| Sfx Sym Pds+ Uni Vio 18in 0 S/A Ct | 207 | 0 | 0% |
| Stratafix Unknown | 198 | 15 | 0.5% |
| Stratafix Knotless Tissue Control Device | 225 | 0 | 0.4% |
| Sfx Spi Pds+ Bi Vio 14in2 Usp1 D/A Ctx | 183 | 101 | 0% |
| Pds Plus Antibacterial Polydioxanone Suture | 156 | 0 | 0% |
| Suture Unknown | 469 | 39 | 0.6% |
| Absorbable Surgical Suture Usp | 361 | 27 | 0% |
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 Pds reports
How many FDA reports name Pds?
211 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 199 in the latest 12 months.
What kinds of events are reported?
malfunction (87.2%) and injury (12.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (61.1%), material separation (23.7%), component misassembled (2.4%), device contaminated during manufacture or shipping (0.9%) and device markings/labelling problem (0.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Pds 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.