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2026 data FDA MAUDE openFDA FDA Class II

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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 §870.3470 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Patch LIGHT-BOOK · MAUDE

#571 of 1000 · 1,498 reports · 1993–2026

  • BOOK 1,498 reports
  • RANK #571 of 1000
  • DEATH 215 death-typed
  • INJ 842 injury-typed
  • MALF 423 malfunction
  • SPAN 1993–2026
  • PEAK 2015: 171
  • PHOTO Instrument

Nearest event-volume peer: Instrument, Cutting, Orthopedic (2 report gap)

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene sits #571 of 1000 among tracked device types with 1,498 MAUDE reports spanning 1993–2026. 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 sit below the device-type norm

Patch carries 28.2% MALFUNCTION-coded reports, 36.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 14.4% corpus 1.5% · above corpus mean (+12.8 pp)
  • INJ 56.2% corpus 30.3% · above corpus mean (+25.9 pp)
  • MALF 28.2% corpus 64.8% · below corpus mean (-36.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 21% of coded problems · Lead manufacturer BARD PERIPHERAL VASCULAR, INC. accounts for 42% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Patch in the event-volume neighbourhood

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

reports

What this shows Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene carries 1,498 MAUDE reports, ranked #571 of 1000.

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

Event Types

Injury 842 (56.2%)
Malfunction 423 (28.2%)
Death 215 (14.4%)
Other 13 (0.9%)
5 (0.3%)

Patient Outcomes

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

Required Intervention 467 (27.3%)
369 (21.6%)
Other 283 (16.6%)
Death 213 (12.5%)
Hospitalization 116 (6.8%)
R 115 (6.7%)
L 41 (2.4%)
Life Threatening 31 (1.8%)
H 24 (1.4%)
O 20 (1.2%)
Congenital Anomaly 10 (0.6%)
S 9 (0.5%)
Disability 8 (0.5%)
D 1 (0.1%)
Invalid Data 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 288
Insufficient Device Problem Information 196
Unknown (for use when the device problem is not known) 161
Incomplete or Missing Packaging 101
Leak/Splash 81
Device remains implanted 76
Device Operates Differently Than Expected 72
Device Contamination with Chemical or Other Material 71
Explanted 44
Off-Label Use 34
Restricted Flow rate 33
Material Rupture 27
Fluid/Blood Leak 24
Nonstandard Device 24
Replace 24
Delamination 22
Appropriate Device Problem Term/Code Not Available 21
Improper or Incorrect Procedure or Method 20
Product Quality Problem 19
Material Split, Cut or Torn 18

Yearly Trend

93
1993: 1
96
1996: 17
97
1997: 30
98
1998: 16
99
1999: 16
00
2000: 10
01
2001: 6
02
2002: 16
03
2003: 3
04
2004: 10
05
2005: 3
06
2006: 2
07
2007: 50
08
2008: 6
09
2009: 109
10
2010: 81
11
2011: 47
12
2012: 21
13
2013: 69
14
2014: 93
15
2015: 171
16
2016: 66
17
2017: 30
18
2018: 44
19
2019: 55
20
2020: 121
21
2021: 80
22
2022: 77
23
2023: 40
24
2024: 49
25
2025: 122
26
2026: 37

Reports rose to 122 in 2025, up from an average of 45 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Top Manufacturers

BARD PERIPHERAL VASCULAR, INC. 214
EDWARDS LIFESCIENCES 200
BAXTER HEALTHCARE CORPORATION 61
W.L. GORE & ASSOCIATES 34

Event Locations

864 (57.7%)
I 429 (28.6%)
HOSPITAL 174 (11.6%)
NO INFORMATION 16 (1.1%)
INVALID DATA 4 (0.3%)
HOME 3 (0.2%)
OPERATING ROOM 2 (0.1%)
OTHER 2 (0.1%)
UNKNOWN 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
CLINIC - WALK IN, OTHER 1 (0.1%)

Compare BARD PERIPHERAL VASCULAR, INC. vs EDWARDS LIFESCIENCES →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Patch: 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 (1,498 here).

Instrument, Cutting, Orthopedic 1,496 Endoscope, Rigid 1,495 Sterilizer, Steam 1,502 Washer, Bolt Nut 1,494

Similar death-typed counts

Nearest other device types by death-typed report count (215 here), distinct from the volume row.

Catheter 218 Stent, Iliac 211 System, X-Ray, Tomography, Computed 219 Percutaneous Cardiac Ablation Catheter For… 210

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

Disclaimer: MAUDE figures for Patch 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 Patch; 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.