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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §878.4840 (General, Plastic Surgery panel).

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FDA MAUDE casebook

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

#170 of 1000 · 15,866 reports · 2006–2026

  • BOOK 15,866 reports
  • RANK #170 of 1000
  • DEATH 41 death-typed
  • INJ 3,335 injury-typed
  • MALF 12,209 malfunction
  • SPAN 2006–2026
  • PEAK 2025: 2,547
  • PHOTO Dressing

Nearest event-volume peer: Dressing, Wound, Occlusive (91 report gap)

Suture, Surgical, Absorbable, Polydioxanone sits #170 of 1000 among tracked device types with 15,866 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 →

Malfunction reports run above the device-type norm

Suture, Surgical, Absorbable, Polydioxanone carries 77.0% MALFUNCTION-coded reports, 12.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 21.0% corpus 30.3% · below corpus mean (-9.3 pp)
  • MALF 77.0% corpus 64.8% · above corpus mean (+12.1 pp)

Lead product-problem code Break is 50% of coded problems · Lead manufacturer ETHICON INC. accounts for 96% of manufacturer-tagged reports · Top event location is 66% 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 15,866 MAUDE reports, ranked #170 of 1000.

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

Event Types

Malfunction 12,209 (77.0%)
Injury 3,335 (21.0%)
Other 247 (1.6%)
Death 41 (0.3%)
34 (0.2%)

Patient Outcomes

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

11,912 (74.9%)
Required Intervention 2,847 (17.9%)
Other 789 (5.0%)
R 154 (1.0%)
Hospitalization 65 (0.4%)
O 64 (0.4%)
Death 31 (0.2%)
Disability 18 (0.1%)
D 9 (0.1%)
Life Threatening 7 (0.0%)
H 6 (0.0%)
S 4 (0.0%)
L 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 8,039
Material Separation 3,165
Adverse Event Without Identified Device or Use Problem 1,969
Positioning Failure 455
Material Integrity Problem 390
Appropriate Device Problem Term/Code Not Available 324
Detachment of Device or Device Component 218
Detachment Of Device Component 189
Insufficient Device Problem Information 162
Material Frayed 131
Other (for use when an appropriate device code cannot be identified) 124
Patient Device Interaction Problem 122
Failure To Adhere Or Bond 111
Defective Component 105
Needle, separation 97
Device Markings/Labelling Problem 79
Migration 73
Tear, Rip or Hole in Device Packaging 72
Delivered as Unsterile Product 66
Device Operates Differently Than Expected 63

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: 1,338

Reports in 2025 (2,547) held close to the prior two-year average of 2,045.

Related Entities for Suture, Surgical, Absorbable, Polydioxanone

Top Manufacturers

ETHICON INC. 14,154
ETHICON, INC. 251
B. BRAUN SURGICAL, S.A. 188
B. BRAUN SURGICAL S.A. 62
TELEFLEX MEDICAL 58

Event Locations

10,449 (65.9%)
I 4,938 (31.1%)
HOSPITAL 332 (2.1%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Suture, Surgical, Absorbable, Polydioxanone: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (15,866 here).

Dressing, Wound, Occlusive 15,775 Catheter, Urological And Accessories 16,326 Endoscopic Ultrasound System 16,331 Prosthesis 16,332

Similar death-typed counts

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

Filter, Bacterial, Breathing-Circuit 41 Hysteroscope 41 Source, Brachytherapy, Radionuclide 41 Stimulator 41

Read our methodology - how this data is sourced, computed, and verified.

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.