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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Patch LIGHT-BOOK · MAUDE

#566 of 1000 · 1,463 reports · 1993–2026

  • BOOK 1,463 reports
  • RANK #566 of 1000
  • DEATH 213 death-typed
  • INJ 814 injury-typed
  • MALF 418 malfunction
  • SPAN 1993–2026
  • PEAK 2015: 171
  • PHOTO Lift

Nearest event-volume peer: Lift, Patient, Ac-Powered (1 report gap)

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene sits #566 of 1000 among tracked device types with 1,463 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 →

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 14.6% corpus 1.5% · above corpus mean (+13.0 pp)
  • INJ 55.6% corpus 30.4% · above corpus mean (+25.2 pp)
  • MALF 28.6% corpus 64.5% · below corpus mean (-35.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Lead manufacturer BARD PERIPHERAL VASCULAR, INC. accounts for 42% of manufacturer-tagged reports · Top event location is 57% 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 1,463 MAUDE reports, ranked #566 of 1000.

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

Event Types

Injury 814 (55.6%)
Malfunction 418 (28.6%)
Death 213 (14.6%)
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 463 (27.8%)
364 (21.8%)
Other 259 (15.5%)
Death 211 (12.7%)
Hospitalization 115 (6.9%)
R 114 (6.8%)
L 39 (2.3%)
Life Threatening 31 (1.9%)
H 23 (1.4%)
O 19 (1.1%)
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 218
Incomplete or Missing Packaging 101
Device Contamination with Chemical or Other Material 67
Insufficient Information 63
Off-Label Use 28
Nonstandard Device 18
Product Quality Problem 16
Missing Information 15
Material Split, Cut or Torn 14
Improper or Incorrect Procedure or Method 13
Unsealed Device Packaging 13
Difficult to Open or Remove Packaging Material 12
Material Rupture 12
Peeled/Delaminated 9
Appropriate Term/Code Not Available 8
Delamination 7
Detachment of Device or Device Component 7
Fluid/Blood Leak 7
Leak/Splash 7
Material Distortion 7

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: 2

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

Top Manufacturers

BARD PERIPHERAL VASCULAR, INC. 213
EDWARDS LIFESCIENCES 200
BAXTER HEALTHCARE CORPORATION 61
W.L. GORE & ASSOCIATES 34

Event Locations

830 (56.7%)
I 429 (29.3%)
HOSPITAL 174 (11.9%)
NO INFORMATION 16 (1.1%)
INVALID DATA 4 (0.3%)
HOME 3 (0.2%)
OPERATING ROOM 2 (0.1%)
UNKNOWN 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
CLINIC - WALK IN, OTHER 1 (0.1%)
OTHER 1 (0.1%)

Compare BARD PERIPHERAL VASCULAR, INC. vs EDWARDS LIFESCIENCES →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Patch, 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 (1,463 here).

Lift, Patient, Ac-Powered 1,464 Instrument, Cutting, Orthopedic 1,465 Radioimmunoassay, Parathyroid Hormone 1,465 Indicator, Biological Sterilization Process 1,469

Similar death-typed counts

Nearest other device types by death-typed report count (213 here), distinct from the volume row.

Alternate Controller Enabled Insulin Infusi… 213 Catheter 212 Shunt, Central Nervous System And Components 212 System, X-Ray, Tomography, Computed 219

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.