What are FDA adverse event reports for Suture, Nonabsorbable, Synthetic, Polyester?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Suture, Nonabsorbable, Synthetic, Polyester, there are 824 total reports including 9 death reports and 350 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, Synthetic, Polyester?

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, Synthetic, Polyester

Name: Suture, Nonabsorbable, Synthetic, Polyester - 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, Synthetic, Polyester LIGHT-BOOK · MAUDE

#704 of 1000 · 824 reports · 1992–2025

BOOK 824 reports
RANK #704 of 1000
DEATH 9 death-typed
INJ 350 injury-typed
MALF 454 malfunction
SPAN 1992–2025
PEAK 2002: 98
PHOTO Forceps, Ophthalmic

Nearest event-volume peer: Forceps, Ophthalmic (1 report gap)

Suture, Nonabsorbable, Synthetic, Polyester sits #704 of 1000 among tracked device types with 824 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 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
INJ 42.5% corpus 30.4% · above corpus mean (+12.0 pp)
MALF 55.1% corpus 64.5% · below corpus mean (-9.4 pp)

Lead product-problem code Break is 33% of coded problems · Lead manufacturer ETHICON, INC. accounts for 56% of manufacturer-tagged reports · Top event location HOSPITAL is 59% of location-tagged rows .

Unit

828
Hammer

827
Suture (this)

824
Forceps

823
Instruments

820
Plate

816

What this shows Suture, Nonabsorbable, Synthetic, Polyester carries 824 MAUDE reports, ranked #704 of 1000.

Event Types

Malfunction 454 (55.1%)

Injury 350 (42.5%)

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.

416 (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%)

Yearly Trend

1992: 2

1995: 1

1996: 10

1997: 59

1998: 34

1999: 37

2000: 24

2001: 70

2002: 98

2003: 74

2004: 34

2005: 37

2006: 40

2007: 35

2008: 47

2009: 56

2010: 24

2011: 25

2012: 73

2013: 21

2014: 12

2015: 1

2016: 2

2018: 3

2020: 1

2024: 1

2025: 3

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%)

146 (17.7%)

OTHER 89 (10.8%)

AMBULATORY SURGICAL FACILITY 40 (4.9%)

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 similar MAUDE profiles

Two openFDA-derived peer sets for Suture, Nonabsorbable, Synthetic, Polyester, 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 (824 here).

Forceps, Ophthalmic 823 Hammer, Surgical 827 Instruments, Surgical, Cardiovascular 820 Unit, Cautery, Thermal, Ac-Powered 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.

Suture, Nonabsorbable, Synthetic, Polyester

Event-type mix vs corpus