2026 data FDA MAUDE openFDA

Suture, Surgical, Absorbable, Polydioxanone

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Suture, Surgical, Absorbable, Polydioxanone MID-BOOK · MAUDE

#168 of 1000 · 14,884 reports · 2006–2026

  • BOOK 14,884 reports
  • RANK #168 of 1000
  • DEATH 41 death-typed
  • INJ 3,188 injury-typed
  • MALF 11,374 malfunction
  • SPAN 2006–2026
  • PEAK 2025: 2,547
  • PHOTO Pump

Nearest event-volume peer: Pump, Infusion, Enteral (93 report gap)

Suture, Surgical, Absorbable, Polydioxanone sits #168 of 1000 among tracked device types with 14,884 MAUDE reports spanning 2006–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 21.4% corpus 30.4% · below corpus mean (-9.0 pp)
  • MALF 76.4% corpus 64.5% · above corpus mean (+11.9 pp)

Lead product-problem code Break is 50% of coded problems · Lead manufacturer ETHICON INC. accounts for 98% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Suture, Surgical, Absorbable, Polydioxanone in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Suture, Surgical, Absorbable, Polydioxanone carries 14,884 MAUDE reports, ranked #168 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 11,374 (76.4%)
Injury 3,188 (21.4%)
Other 247 (1.7%)
Death 41 (0.3%)
34 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

11,240 (74.5%)
Required Intervention 2,766 (18.3%)
Other 735 (4.9%)
R 150 (1.0%)
Hospitalization 64 (0.4%)
O 60 (0.4%)
Death 31 (0.2%)
Disability 18 (0.1%)
D 9 (0.1%)
Life Threatening 8 (0.1%)
H 4 (0.0%)
S 4 (0.0%)
L 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 7,118
Material Separation 2,889
Adverse Event Without Identified Device or Use Problem 1,825
Positioning Failure 382
Material Integrity Problem 355
Appropriate Term/Code Not Available 287
Detachment of Device or Device Component 203
Detachment Of Device Component 170
Patient Device Interaction Problem 122
Material Frayed 121
Defective Component 102
Failure To Adhere Or Bond 97
Device Markings/Labelling Problem 73
Migration 73
Delivered as Unsterile Product 62
Tear, Rip or Hole in Device Packaging 62
Positioning Problem 60
Material Twisted/Bent 48
Component Misassembled 46
Insufficient Information 45

Yearly Trend

06
2006: 2
07
2007: 7
08
2008: 29
09
2009: 42
10
2010: 115
11
2011: 59
12
2012: 82
13
2013: 185
14
2014: 274
15
2015: 280
16
2016: 321
17
2017: 461
18
2018: 900
19
2019: 1,122
20
2020: 1,010
21
2021: 1,466
22
2022: 1,537
23
2023: 1,975
24
2024: 2,114
25
2025: 2,547
26
2026: 356

Related Entities for Suture, Surgical, Absorbable, Polydioxanone

Top Manufacturers

Event Locations

9,469 (63.6%)
I 4,938 (33.2%)
HOSPITAL 330 (2.2%)
OTHER 74 (0.5%)
NO INFORMATION 61 (0.4%)
HOME 11 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare ETHICON INC. vs ETHICON, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Suture, Surgical, Absorbable, Polydioxanone, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (14,884 here).

Similar death-typed counts

Nearest other device types by death-typed report count (41 here), distinct from the volume row.

Disclaimer: MAUDE figures for Suture, Surgical, Absorbable, Polydioxanone are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Suture, Surgical, Absorbable, Polydioxanone; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.