What are FDA adverse event reports for Suture, Nonabsorbable?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Suture, Nonabsorbable, there are 592 total reports including 10 death reports and 338 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Suture, Nonabsorbable?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2025 data FDA MAUDE openFDA

Suture, Nonabsorbable

Name: Suture, Nonabsorbable - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

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

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Suture, Nonabsorbable LIGHT-BOOK · MAUDE

#815 of 1000 · 592 reports · 1992–2025

BOOK 592 reports
RANK #815 of 1000
DEATH 10 death-typed
INJ 338 injury-typed
MALF 223 malfunction
SPAN 1992–2025
PEAK 2011: 50
PHOTO Cutter, Surgical

Nearest event-volume peer: Cutter, Surgical (1 report gap)

Suture, Nonabsorbable sits #815 of 1000 among tracked device types with 592 MAUDE reports spanning 1992–2025. 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 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
INJ 57.1% corpus 30.4% · above corpus mean (+26.7 pp)
MALF 37.7% corpus 64.5% · below corpus mean (-26.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 40% of coded problems · Lead manufacturer ETHICON, INC. accounts for 47% of manufacturer-tagged reports · Top event location HOSPITAL is 45% of location-tagged rows .

Endoscope

596
Cutter

593
Suture (this)

592
Centrifuges F…

588
Guide

588
Mixer

588

What this shows Suture, Nonabsorbable carries 592 MAUDE reports, ranked #815 of 1000.

Event Types

Injury 338 (57.1%)

Malfunction 223 (37.7%)

11 (1.9%)

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 272 (43.5%)

217 (34.7%)

Other 64 (10.2%)

Hospitalization 23 (3.7%)

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%)

Yearly Trend

1992: 2

1993: 3

1994: 5

1995: 14

1996: 12

1997: 17

1998: 16

1999: 17

2000: 34

2001: 31

2002: 42

2003: 38

2004: 25

2005: 14

2006: 17

2007: 22

2008: 16

2009: 17

2010: 17

2011: 50

2012: 28

2013: 44

2014: 6

2015: 6

2016: 7

2017: 4

2018: 6

2019: 14

2020: 3

2021: 8

2022: 13

2023: 5

2024: 12

2025: 27

Top Manufacturers

ETHICON, INC. 141

ETHICON INC. 98

UNITED STATES SURGICAL CORP. 27

TELEFLEX MEDICAL 19

ETHICON, INC 17

Event Locations

HOSPITAL 264 (44.6%)

146 (24.7%)

OTHER 77 (13.0%)

I 49 (8.3%)

UNKNOWN 23 (3.9%)

INVALID DATA 13 (2.2%)

HOME 11 (1.9%)

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 similar MAUDE profiles

Two openFDA-derived peer sets for Suture, Nonabsorbable, 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 (592 here).

Cutter, Surgical 593 Centrifuges For Clinical Use 588 Endoscope 596 Guide, Wire, Catheter, Neurovasculature 588

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 Cabinet, Table And Tray, Anesthesia 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.

Suture, Nonabsorbable

Event-type mix vs corpus