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2026 data FDA MAUDE openFDA FDA Class II

Suture, Nonabsorbable, Synthetic, Polyester

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 §878.5000 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Suture, Nonabsorbable, Synthetic, Polyester LIGHT-BOOK · MAUDE

#718 of 1000 · 825 reports · 1992–2026

  • BOOK 825 reports
  • RANK #718 of 1000
  • DEATH 9 death-typed
  • INJ 350 injury-typed
  • MALF 455 malfunction
  • SPAN 1992–2026
  • PEAK 2002: 98
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Hemodialysis, Triple Lumen, Non-Implanted (0 report gap)

Suture, Nonabsorbable, Synthetic, Polyester sits #718 of 1000 among tracked device types with 825 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 →

Injury-coded reports run above the device-type norm

Suture, Nonabsorbable, Synthetic, Polyester carries 42.4% INJURY-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 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 42.4% corpus 30.3% · above corpus mean (+12.1 pp)
  • MALF 55.2% corpus 64.8% · below corpus mean (-9.7 pp)

Lead product-problem code Break is 19% of coded problems · Lead manufacturer ETHICON, INC. accounts for 56% of manufacturer-tagged reports · Top event location HOSPITAL is 59% of location-tagged rows .

Suture, Nonabsorbable, Synthetic, Polyester in the event-volume neighbourhood

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

reports

What this shows Suture, Nonabsorbable, Synthetic, Polyester carries 825 MAUDE reports, ranked #718 of 1000.

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

Event Types

Malfunction 455 (55.2%)
Injury 350 (42.4%)
Death 9 (1.1%)
Other 9 (1.1%)
2 (0.2%)

Patient Outcomes

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

417 (48.9%)
Required Intervention 247 (29.0%)
Other 125 (14.7%)
R 19 (2.2%)
Hospitalization 15 (1.8%)
Death 9 (1.1%)
Life Threatening 9 (1.1%)
Disability 4 (0.5%)
L 2 (0.2%)
O 2 (0.2%)
S 2 (0.2%)
H 1 (0.1%)

Top Product Problems

Break 220
Device, or device fragments remain in patient 146
Replace 129
Other (for use when an appropriate device code cannot be identified) 121
Positioning Failure 57
Suture line disruption 53
Unknown (for use when the device problem is not known) 49
Suture line separation 47
Explanted 44
Component(s), broken 41
Reaction 39
Device remains implanted 38
Device Issue 35
Difficult or Delayed Positioning 30
Detachment Of Device Component 24
Loose 22
Sticking 22
Device, removal of (non-implant) 21
Difficult to Insert 16
Unraveled Material 16

Yearly Trend

92
1992: 2
95
1995: 1
96
1996: 10
97
1997: 59
98
1998: 34
99
1999: 37
00
2000: 24
01
2001: 70
02
2002: 98
03
2003: 74
04
2004: 34
05
2005: 37
06
2006: 40
07
2007: 35
08
2008: 47
09
2009: 56
10
2010: 24
11
2011: 25
12
2012: 73
13
2013: 21
14
2014: 12
15
2015: 1
16
2016: 2
18
2018: 3
20
2020: 1
24
2024: 1
25
2025: 3
26
2026: 1

Reports rose to 3 in 2025, up from an average of 1 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Suture, Nonabsorbable, Synthetic, Polyester

Top Manufacturers

ETHICON, INC. 178
UNITED STATES SURGICAL CORP. 58
PONCE - USS 38
ETHICON, INC 23
ETHICON INC. 21

Event Locations

HOSPITAL 484 (58.7%)
147 (17.8%)
OTHER 89 (10.8%)
AMBULATORY SURGICAL FACILITY 40 (4.8%)
UNKNOWN 37 (4.5%)
INVALID DATA 12 (1.5%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.6%)
HOME 3 (0.4%)
NO INFORMATION 3 (0.4%)
AMBULATORY SURGICAL CENTER 1 (0.1%)
I 1 (0.1%)
NOT APPLICABLE 1 (0.1%)
OPERATING ROOM 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare ETHICON, INC. vs UNITED STATES SURGICAL CORP. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Suture, Nonabsorbable, Synthetic, Polyester: 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 (825 here).

Catheter 825 Plate 824 Device, Fixation, Tracheal Tube 822 Device, Warming. Blood And Plasma 828

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

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

Disclaimer: MAUDE figures for Suture, Nonabsorbable, Synthetic, Polyester 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, Nonabsorbable, Synthetic, Polyester; 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.