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2026 data FDA MAUDE openFDA FDA Class I

Bag, Urine Collection, Leg, For External Use, Sterile

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 §876.5250 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Bag LIGHT-BOOK · MAUDE

#970 of 1000 · 399 reports · 1994–2026

  • BOOK 399 reports
  • RANK #970 of 1000
  • DEATH 0 death-typed
  • INJ 70 injury-typed
  • MALF 326 malfunction
  • SPAN 1994–2026
  • PEAK 2021: 70
  • PHOTO Diazo Colorimetry

Nearest event-volume peer: Diazo Colorimetry, Bilirubin (0 report gap)

Bag, Urine Collection, Leg, For External Use, Sterile sits #970 of 1000 among tracked device types with 399 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

Bag carries 81.7% MALFUNCTION-coded reports, 16.9pp above 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 17.5% corpus 30.3% · below corpus mean (-12.7 pp)
  • MALF 81.7% corpus 64.8% · above corpus mean (+16.9 pp)

Lead product-problem code Restricted Flow rate is 35% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 68% of manufacturer-tagged reports · Top event location is 74% of location-tagged rows .

Bag in the event-volume neighbourhood

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

reports

What this shows Bag, Urine Collection, Leg, For External Use, Sterile carries 399 MAUDE reports, ranked #970 of 1000.

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

Event Types

Malfunction 326 (81.7%)
Injury 70 (17.5%)
3 (0.8%)

Patient Outcomes

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

Other 199 (49.1%)
137 (33.8%)
Required Intervention 57 (14.1%)
R 5 (1.2%)
Hospitalization 4 (1.0%)
L 1 (0.2%)
S 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Restricted Flow rate 128
Leak/Splash 37
Component Missing 29
Partial Blockage 29
Biocompatibility 16
Deformation Due to Compressive Stress 16
No Flow 15
Fluid/Blood Leak 13
Sticking 11
Obstruction of Flow 10
Material Twisted/Bent 9
Occlusion Within Device 9
Adverse Event Without Identified Device or Use Problem 7
Device Issue 7
Device Operates Differently Than Expected 7
Complete Blockage 6
Component Misassembled 6
Valve(s), defective 6
Malfunction 5
Infusion or Flow Problem 4

Yearly Trend

94
1994: 2
97
1997: 1
98
1998: 4
99
1999: 3
00
2000: 7
01
2001: 9
02
2002: 23
03
2003: 15
04
2004: 6
05
2005: 1
07
2007: 1
08
2008: 3
09
2009: 3
10
2010: 17
11
2011: 12
12
2012: 13
13
2013: 9
14
2014: 4
15
2015: 1
16
2016: 13
17
2017: 22
18
2018: 3
19
2019: 3
20
2020: 1
21
2021: 70
22
2022: 48
23
2023: 36
24
2024: 42
25
2025: 16
26
2026: 11

Reports fell to 16 in 2025, down from an average of 39 in the two years before.

Related Entities for Bag, Urine Collection, Leg, For External Use, Sterile

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 184
COLOPLAST A/S 41
C.R. BARD INC. (COVINGTON) -1018233 37
TELEFLEX MEDICAL 7
COVIDIEN 3

Event Locations

297 (74.4%)
I 81 (20.3%)
HOME 9 (2.3%)
HOSPITAL 9 (2.3%)
AMBULATORY SURGICAL FACILITY 1 (0.3%)
NO INFORMATION 1 (0.3%)
NURSING HOME 1 (0.3%)

Compare C.R. BARD, INC. (COVINGTON) -1018233 vs COLOPLAST A/S →

Nationwide devices with a comparable report-volume footprint

Bag 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 (399 here).

Diazo Colorimetry, Bilirubin 399 Device, Percutaneous Retrieval 398 Probe, Blood-Flow, Extravascular 398 Device, Medical Examination, Ac Powered 401

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 Bag 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 Bag; 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.