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2026 data FDA MAUDE openFDA FDA Class II

Suture, Absorbable, Natural

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).

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FDA MAUDE casebook

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

#451 of 1000 · 2,489 reports · 1994–2026

  • BOOK 2,489 reports
  • RANK #451 of 1000
  • DEATH 5 death-typed
  • INJ 569 injury-typed
  • MALF 1,888 malfunction
  • SPAN 1994–2026
  • PEAK 2018: 246
  • PHOTO Tube, Bronchial

Nearest event-volume peer: Tube, Bronchial (W/Wo Connector) (14 report gap)

Suture, Absorbable, Natural sits #451 of 1000 among tracked device types with 2,489 MAUDE reports spanning 1994–2026. 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 run above the device-type norm

Suture, Absorbable, Natural carries 75.9% MALFUNCTION-coded reports, 11.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 22.9% corpus 30.3% · below corpus mean (-7.4 pp)
  • MALF 75.9% corpus 64.8% · above corpus mean (+11.0 pp)

Lead product-problem code Break is 44% of coded problems · Lead manufacturer ETHICON INC. accounts for 63% of manufacturer-tagged reports · Top event location is 40% of location-tagged rows .

Suture, Absorbable, Natural in the event-volume neighbourhood

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

reports

What this shows Suture, Absorbable, Natural carries 2,489 MAUDE reports, ranked #451 of 1000.

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

Event Types

Malfunction 1,888 (75.9%)
Injury 569 (22.9%)
Other 16 (0.6%)
11 (0.4%)
Death 5 (0.2%)

Patient Outcomes

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

1,613 (63.8%)
Required Intervention 448 (17.7%)
Other 386 (15.3%)
R 33 (1.3%)
Hospitalization 29 (1.1%)
O 6 (0.2%)
S 5 (0.2%)
Death 4 (0.2%)
H 1 (0.0%)
L 1 (0.0%)
Disability 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Break 1,040
Material Separation 220
Other (for use when an appropriate device code cannot be identified) 177
Adverse Event Without Identified Device or Use Problem 90
Material Frayed 87
Suture line disruption 87
Detachment of Device or Device Component 85
Appropriate Device Problem Term/Code Not Available 77
Detachment Of Device Component 61
Fluid/Blood Leak 54
Reaction 52
Needle, separation 47
Absorption 46
Component(s), broken 45
Material Integrity Problem 44
Patient-Device Incompatibility 40
Replace 40
Leak/Splash 30
Unknown (for use when the device problem is not known) 29
Device Issue 27

Yearly Trend

94
1994: 7
95
1995: 10
96
1996: 32
97
1997: 149
98
1998: 80
99
1999: 49
00
2000: 40
01
2001: 8
02
2002: 38
03
2003: 12
04
2004: 6
05
2005: 20
06
2006: 17
07
2007: 13
08
2008: 6
09
2009: 25
10
2010: 57
11
2011: 36
12
2012: 27
13
2013: 32
14
2014: 157
15
2015: 137
16
2016: 87
17
2017: 133
18
2018: 246
19
2019: 229
20
2020: 109
21
2021: 120
22
2022: 130
23
2023: 121
24
2024: 161
25
2025: 120
26
2026: 75

Reports in 2025 (120) held close to the prior two-year average of 141.

Related Entities for Suture, Absorbable, Natural

Top Manufacturers

ETHICON INC. 1,171
DAVIS & GECK CARIBE LTD 263
ETHICON, INC. 213
UNITED STATES SURGICAL CORP. 100
B. BRAUN SURGICAL S.A. 77
UNITED STATES SURGICAL CORPORATION 22
COVIDIEN 21

Event Locations

1,007 (40.5%)
I 918 (36.9%)
HOSPITAL 346 (13.9%)
OTHER 79 (3.2%)
UNKNOWN 42 (1.7%)
INVALID DATA 35 (1.4%)
OUTPATIENT TREATMENT FACILITY 24 (1.0%)
NO INFORMATION 16 (0.6%)
AMBULATORY SURGICAL FACILITY 10 (0.4%)
HOME 8 (0.3%)
NOT APPLICABLE 2 (0.1%)
OPERATING ROOM 2 (0.1%)

Compare ETHICON INC. vs DAVIS & GECK CARIBE LTD →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Suture, Absorbable, Natural: 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 (2,489 here).

Tube, Bronchial 2,475 Aid, Transfer 2,515 Prosthesis 2,520 Gauze/Sponge, Internal, X-Ray Detectable 2,521

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

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

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