PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Suture, Absorbable, Synthetic

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 §878.4830 (General, Plastic Surgery panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Suture, Absorbable, Synthetic LIGHT-BOOK · MAUDE

#301 of 1000 · 5,585 reports · 1992–2026

  • BOOK 5,585 reports
  • RANK #301 of 1000
  • DEATH 8 death-typed
  • INJ 1,984 injury-typed
  • MALF 3,583 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 450
  • PHOTO Pump, Breast, Powered

Nearest event-volume peer: Pump, Breast, Powered (29 report gap)

Suture, Absorbable, Synthetic sits #301 of 1000 among tracked device types with 5,585 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, Absorbable, Synthetic carries 35.5% INJURY-coded reports, 5.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 35.5% corpus 30.3% · above corpus mean (+5.2 pp)
  • MALF 64.2% corpus 64.8% · below corpus mean (-0.7 pp)

Lead product-problem code Break is 31% of coded problems · Lead manufacturer ETHICON INC. accounts for 73% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .

Suture, Absorbable, Synthetic in the event-volume neighbourhood

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

reports

What this shows Suture, Absorbable, Synthetic carries 5,585 MAUDE reports, ranked #301 of 1000.

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

Event Types

Malfunction 3,583 (64.2%)
Injury 1,984 (35.5%)
Death 8 (0.1%)
7 (0.1%)
Other 3 (0.1%)

Patient Outcomes

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

3,607 (63.7%)
Required Intervention 1,485 (26.2%)
Other 395 (7.0%)
Hospitalization 77 (1.4%)
R 74 (1.3%)
Death 7 (0.1%)
Life Threatening 6 (0.1%)
S 4 (0.1%)
L 3 (0.1%)
O 3 (0.1%)
Disability 2 (0.0%)

Top Product Problems

Break 1,860
Material Separation 931
Adverse Event Without Identified Device or Use Problem 627
Suture line disruption 526
Other (for use when an appropriate device code cannot be identified) 295
Reaction 219
Replace 170
Appropriate Device Problem Term/Code Not Available 157
Device Issue 143
Suture line separation 142
Unknown (for use when the device problem is not known) 123
Detachment Of Device Component 120
Component(s), broken 118
Explanted 117
Needle, separation 101
Material Integrity Problem 64
Tear, Rip or Hole in Device Packaging 56
Material Frayed 55
Component Misassembled 42
Tip breakage 39

Yearly Trend

92
1992: 2
94
1994: 6
95
1995: 12
96
1996: 156
97
1997: 381
98
1998: 128
99
1999: 123
00
2000: 111
01
2001: 131
02
2002: 168
03
2003: 61
04
2004: 51
05
2005: 67
06
2006: 72
07
2007: 86
08
2008: 124
09
2009: 67
10
2010: 23
11
2011: 62
12
2012: 157
13
2013: 103
14
2014: 92
15
2015: 76
16
2016: 63
17
2017: 67
18
2018: 400
19
2019: 434
20
2020: 278
21
2021: 301
22
2022: 327
23
2023: 343
24
2024: 450
25
2025: 423
26
2026: 240

Reports in 2025 (423) held close to the prior two-year average of 397.

Related Entities for Suture, Absorbable, Synthetic

Top Manufacturers

ETHICON INC. 3,503
ETHICON, INC. 562
UNITED STATES SURGICAL CORP. 524
UNITED STATES SURGICAL CORPORATION 100
NORTH HAVEN - USS 81
UNITED STATES SURGICAL CORP 35

Event Locations

2,406 (43.1%)
I 1,488 (26.6%)
HOSPITAL 1,260 (22.6%)
OTHER 241 (4.3%)
UNKNOWN 134 (2.4%)
HOME 20 (0.4%)
INVALID DATA 19 (0.3%)
NO INFORMATION 6 (0.1%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)
OPERATING ROOM 2 (0.0%)
NURSING HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
REHABILITATION CENTER 1 (0.0%)

Compare ETHICON INC. vs ETHICON, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Suture, Absorbable, Synthetic: 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 (5,585 here).

Pump, Breast, Powered 5,556 Prosthesis 5,649 Prosthesis 5,676 Warmer, Infant Radiant 5,708

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Agent 8 Bronchoscope Accessory 8 Catheter, Balloon, Transcervical 8 Catheter, Nephrostomy 8

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

Disclaimer: MAUDE figures for Suture, Absorbable, Synthetic 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, Absorbable, Synthetic; 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.