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2026 data FDA MAUDE openFDA FDA Class I

Needle, Suturing, Disposable

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4800 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Needle, Suturing, Disposable LIGHT-BOOK · MAUDE

#853 of 1000 · 559 reports · 1992–2026

  • BOOK 559 reports
  • RANK #853 of 1000
  • DEATH 0 death-typed
  • INJ 155 injury-typed
  • MALF 367 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 59
  • PHOTO Device

Nearest event-volume peer: Device, Urine Flow Rate Measuring, Non-Electrical, Disposable (2 report gap)

Needle, Suturing, Disposable sits #853 of 1000 among tracked device types with 559 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 sit below the device-type norm

Needle, Suturing, Disposable carries 27.7% INJURY-coded reports, 2.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 27.7% corpus 30.3% · below corpus mean (-2.6 pp)
  • MALF 65.7% corpus 64.8% · above corpus mean (+0.8 pp)

Lead product-problem code Break is 46% of coded problems · Lead manufacturer ETHICON, INC. accounts for 41% of manufacturer-tagged reports · Top event location is 37% of location-tagged rows .

Needle, Suturing, Disposable in the event-volume neighbourhood

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

reports

What this shows Needle, Suturing, Disposable carries 559 MAUDE reports, ranked #853 of 1000.

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

Event Types

Malfunction 367 (65.7%)
Injury 155 (27.7%)
Other 33 (5.9%)
4 (0.7%)

Patient Outcomes

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

320 (53.5%)
Other 122 (20.4%)
Required Intervention 101 (16.9%)
R 30 (5.0%)
Hospitalization 8 (1.3%)
Disability 6 (1.0%)
O 5 (0.8%)
H 2 (0.3%)
L 1 (0.2%)
S 1 (0.2%)
Invalid Data 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Break 288
Tip breakage 57
Fracture 51
Device, or device fragments remain in patient 37
Material Fragmentation 30
Detachment Of Device Component 26
Device Or Device Fragments Location Unknown 17
Device, removal of (non-implant) 16
Bent 13
Component(s), broken 10
Difficult to Remove 10
Adverse Event Without Identified Device or Use Problem 9
Component Missing 9
Detachment of Device or Device Component 8
Device Contaminated During Manufacture or Shipping 7
Insufficient Device Problem Information 7
Material Integrity Problem 7
Material Protrusion/Extrusion 7
Material Separation 7
Patient-Device Incompatibility 7

Yearly Trend

92
1992: 3
93
1993: 5
94
1994: 7
95
1995: 6
96
1996: 9
97
1997: 5
98
1998: 9
99
1999: 5
01
2001: 4
02
2002: 19
03
2003: 22
04
2004: 6
05
2005: 5
06
2006: 6
07
2007: 19
08
2008: 29
09
2009: 19
10
2010: 13
11
2011: 8
12
2012: 6
13
2013: 9
14
2014: 5
15
2015: 12
16
2016: 24
17
2017: 44
18
2018: 59
19
2019: 30
20
2020: 26
21
2021: 17
22
2022: 17
23
2023: 32
24
2024: 26
25
2025: 38
26
2026: 15

Reports in 2025 (38) held close to the prior two-year average of 29.

Related Entities for Needle, Suturing, Disposable

Top Manufacturers

ETHICON, INC. 21
DEPUY MITEK 15
STRYKER ENDOSCOPY-SAN JOSE 15

Event Locations

207 (37.0%)
HOSPITAL 172 (30.8%)
I 136 (24.3%)
NO INFORMATION 22 (3.9%)
AMBULATORY SURGICAL FACILITY 8 (1.4%)
HOME 3 (0.5%)
INVALID DATA 3 (0.5%)
IMAGING CENTER - MOBILE 2 (0.4%)
NURSING HOME 2 (0.4%)
EXAMINATION ROOM 1 (0.2%)
NOT APPLICABLE 1 (0.2%)
OTHER 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare ETHICON, INC. vs DEPUY MITEK →

Nationwide devices with a comparable report-volume footprint

Needle, Suturing, Disposable carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (559 here).

Device 557 Instrument, Ent Manual Surgical 557 Enzymatic Method, Creatinine 563 Prosthesis 555

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Needle, Suturing, Disposable 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 Needle, Suturing, Disposable; 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.