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2026 data FDA MAUDE openFDA

Suture, Nonabsorbable, Synthetic, Polypropylene

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.

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FDA MAUDE casebook

openFDA event book Suture MID-BOOK · MAUDE

#140 of 1000 · 18,518 reports · 1992–2026

  • BOOK 18,518 reports
  • RANK #140 of 1000
  • DEATH 220 death-typed
  • INJ 3,273 injury-typed
  • MALF 14,946 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 2,581
  • PHOTO Suture

Nearest event-volume peer: Suture, Nonabsorbable, Synthetic, Polyethylene (21 report gap)

Suture, Nonabsorbable, Synthetic, Polypropylene sits #140 of 1000 among tracked device types with 18,518 MAUDE reports spanning 1992–2026. 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 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 17.7% corpus 30.4% · below corpus mean (-12.8 pp)
  • MALF 80.7% corpus 64.5% · above corpus mean (+16.2 pp)

Lead product-problem code Break is 45% of coded problems · Lead manufacturer ETHICON INC. accounts for 80% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Suture in the event-volume neighbourhood

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

reports

What this shows Suture, Nonabsorbable, Synthetic, Polypropylene carries 18,518 MAUDE reports, ranked #140 of 1000.

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

Event Types

Malfunction 14,946 (80.7%)
Injury 3,273 (17.7%)
Death 220 (1.2%)
47 (0.3%)
Other 32 (0.2%)

Patient Outcomes

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

14,145 (75.4%)
Required Intervention 2,558 (13.6%)
Other 1,409 (7.5%)
Death 194 (1.0%)
R 183 (1.0%)
Hospitalization 119 (0.6%)
O 39 (0.2%)
Life Threatening 34 (0.2%)
D 22 (0.1%)
H 22 (0.1%)
L 16 (0.1%)
S 9 (0.0%)
Disability 6 (0.0%)
Invalid Data 3 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Break 7,212
Material Separation 4,180
Adverse Event Without Identified Device or Use Problem 1,544
Detachment of Device or Device Component 961
Material Frayed 524
Material Split, Cut or Torn 239
Failure To Adhere Or Bond 178
Material Integrity Problem 165
Appropriate Term/Code Not Available 152
Device Contaminated During Manufacture or Shipping 128
Material Twisted/Bent 101
Device Markings/Labelling Problem 100
Insufficient Information 92
Detachment Of Device Component 71
Component Misassembled 59
Dull, Blunt 52
Device Operates Differently Than Expected 48
Defective Component 46
Delivered as Unsterile Product 45
Unraveled Material 41

Yearly Trend

92
1992: 1
93
1993: 6
94
1994: 13
95
1995: 9
96
1996: 71
97
1997: 427
98
1998: 380
99
1999: 200
00
2000: 123
01
2001: 124
02
2002: 150
03
2003: 88
04
2004: 38
05
2005: 39
06
2006: 56
07
2007: 73
08
2008: 75
09
2009: 71
10
2010: 85
11
2011: 84
12
2012: 194
13
2013: 191
14
2014: 437
15
2015: 422
16
2016: 440
17
2017: 413
18
2018: 685
19
2019: 1,803
20
2020: 1,493
21
2021: 1,652
22
2022: 1,563
23
2023: 1,811
24
2024: 2,348
25
2025: 2,581
26
2026: 372

Related Entities for Suture, Nonabsorbable, Synthetic, Polypropylene

Top Manufacturers

ETHICON INC. 12,201
DAVIS & GECK CARIBE LTD 1,563
ETHICON, INC. 755
TELEFLEX MEDICAL 267
UNITED STATES SURGICAL CORP. 229
W.L. GORE & ASSOCIATES 195

Event Locations

10,371 (56.0%)
I 6,169 (33.3%)
HOSPITAL 1,619 (8.7%)
OTHER 106 (0.6%)
UNKNOWN 82 (0.4%)
INVALID DATA 75 (0.4%)
NO INFORMATION 59 (0.3%)
HOME 22 (0.1%)
AMBULATORY SURGICAL FACILITY 5 (0.0%)
OPERATING ROOM 3 (0.0%)
CRITICAL CARE UNIT 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
NOT APPLICABLE 1 (0.0%)
PATIENT'S ROOM OR WARD 1 (0.0%)
REHABILITATION CENTER 1 (0.0%)

Compare ETHICON INC. vs DAVIS & GECK CARIBE LTD →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Suture, 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 (18,518 here).

Suture 18,497 Tube, Tracheal 18,473 Impactor 18,375 Dorsal Root Ganglion Stimulator For Pain Re… 18,878

Similar death-typed counts

Nearest other device types by death-typed report count (220 here), distinct from the volume row.

Pump, Infusion, Pca 221 Restraint, Protective 221 System, X-Ray, Tomography, Computed 219 System, Hemodynamic, Implantable 225

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

Disclaimer: MAUDE figures for Suture 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; 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.