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2026 data FDA MAUDE openFDA FDA Class II

Suture, Nonabsorbable

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 §878.4495 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Suture, Nonabsorbable LIGHT-BOOK · MAUDE

#828 of 1000 · 601 reports · 1992–2026

  • BOOK 601 reports
  • RANK #828 of 1000
  • DEATH 10 death-typed
  • INJ 341 injury-typed
  • MALF 229 malfunction
  • SPAN 1992–2026
  • PEAK 2011: 50
  • PHOTO Device

Nearest event-volume peer: Device, Anastomotic, Microvascular (0 report gap)

Suture, Nonabsorbable sits #828 of 1000 among tracked device types with 601 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 →

Malfunction reports sit below the device-type norm

Suture, Nonabsorbable carries 38.1% MALFUNCTION-coded reports, 26.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 56.7% corpus 30.3% · above corpus mean (+26.4 pp)
  • MALF 38.1% corpus 64.8% · below corpus mean (-26.7 pp)

Lead product-problem code Break is 26% of coded problems · Lead manufacturer ETHICON, INC. accounts for 46% of manufacturer-tagged reports · Top event location HOSPITAL is 44% of location-tagged rows .

Suture, Nonabsorbable in the event-volume neighbourhood

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

reports

What this shows Suture, Nonabsorbable carries 601 MAUDE reports, ranked #828 of 1000.

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

Event Types

Injury 341 (56.7%)
Malfunction 229 (38.1%)
11 (1.8%)
Death 10 (1.7%)
Other 10 (1.7%)

Patient Outcomes

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

Required Intervention 273 (43.3%)
220 (34.9%)
Other 66 (10.5%)
Hospitalization 23 (3.6%)
R 18 (2.9%)
Death 10 (1.6%)
L 6 (1.0%)
O 5 (0.8%)
Life Threatening 3 (0.5%)
S 2 (0.3%)
Disability 2 (0.3%)
Invalid Data 2 (0.3%)
H 1 (0.2%)

Top Product Problems

Break 172
Other (for use when an appropriate device code cannot be identified) 89
Unknown (for use when the device problem is not known) 51
Adverse Event Without Identified Device or Use Problem 46
Replace 36
Suture line separation 30
Explanted 27
Needle, separation 25
Suture line disruption 24
Detachment Of Device Component 20
Device Issue 19
Material Erosion 19
Reaction 19
Tip breakage 17
Component(s), broken 15
Device, or device fragments remain in patient 15
Material Separation 14
Fracture 10
Material Frayed 10
Device Or Device Fragments Location Unknown 6

Yearly Trend

92
1992: 2
93
1993: 3
94
1994: 5
95
1995: 14
96
1996: 12
97
1997: 17
98
1998: 16
99
1999: 17
00
2000: 34
01
2001: 31
02
2002: 42
03
2003: 38
04
2004: 25
05
2005: 14
06
2006: 17
07
2007: 22
08
2008: 16
09
2009: 17
10
2010: 17
11
2011: 50
12
2012: 28
13
2013: 44
14
2014: 6
15
2015: 6
16
2016: 7
17
2017: 4
18
2018: 6
19
2019: 14
20
2020: 3
21
2021: 8
22
2022: 13
23
2023: 5
24
2024: 12
25
2025: 27
26
2026: 9

Reports rose to 27 in 2025, up from an average of 9 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Suture, Nonabsorbable

Top Manufacturers

ETHICON, INC. 141
ETHICON INC. 105
UNITED STATES SURGICAL CORP. 27
TELEFLEX MEDICAL 19
ETHICON, INC 17

Event Locations

HOSPITAL 264 (43.9%)
155 (25.8%)
OTHER 77 (12.8%)
I 49 (8.2%)
UNKNOWN 23 (3.8%)
INVALID DATA 13 (2.2%)
HOME 11 (1.8%)
AMBULATORY SURGICAL FACILITY 3 (0.5%)
CLINIC - WALK IN, OTHER 2 (0.3%)
AMBULATORY HEALTH CARE FACILITY 1 (0.2%)
NO INFORMATION 1 (0.2%)
NOT APPLICABLE 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare ETHICON, INC. vs ETHICON INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Suture, Nonabsorbable: 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 (601 here).

Device, Anastomotic, Microvascular 601 Neurosurgical Paddie 600 Probe 602 Table, Obstetric 602

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Accessories, Catheter 10 Adaptor, Hygiene 10 Blood Pump For Ecmo, Long-Term Use 10 Chair, Adjustable, Mechanical 10

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

Disclaimer: MAUDE figures for Suture, Nonabsorbable 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; 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.