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2026 data FDA MAUDE openFDA FDA Class II

Tube, Drainage, Suprapubic

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 §876.5090 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Tube, Drainage, Suprapubic LIGHT-BOOK · MAUDE

#785 of 1000 · 677 reports · 1992–2026

  • BOOK 677 reports
  • RANK #785 of 1000
  • DEATH 5 death-typed
  • INJ 248 injury-typed
  • MALF 416 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 78
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Muscle, Powered (1 report gap)

Tube, Drainage, Suprapubic sits #785 of 1000 among tracked device types with 677 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 run above the device-type norm

Tube, Drainage, Suprapubic carries 36.6% INJURY-coded reports, 6.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 36.6% corpus 30.3% · above corpus mean (+6.3 pp)
  • MALF 61.4% corpus 64.8% · below corpus mean (-3.4 pp)

Lead product-problem code Break is 30% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - COSTA RICA (COYOL) accounts for 49% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Tube, Drainage, Suprapubic in the event-volume neighbourhood

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

reports

What this shows Tube, Drainage, Suprapubic carries 677 MAUDE reports, ranked #785 of 1000.

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

Event Types

Malfunction 416 (61.4%)
Injury 248 (36.6%)
7 (1.0%)
Death 5 (0.7%)
Other 1 (0.1%)

Patient Outcomes

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

406 (57.9%)
Required Intervention 168 (24.0%)
Other 76 (10.8%)
R 18 (2.6%)
Hospitalization 18 (2.6%)
Invalid Data 5 (0.7%)
O 4 (0.6%)
Death 4 (0.6%)
L 2 (0.3%)

Top Product Problems

Break 187
Difficult to Remove 77
Detachment of Device or Device Component 41
Fracture 36
Detachment Of Device Component 30
Adverse Event Without Identified Device or Use Problem 29
Tear, Rip or Hole in Device Packaging 25
Device Contamination with Chemical or Other Material 21
Material Separation 21
Calcified 19
Device Damaged Prior to Use 19
Defective Device 16
Device Dislodged or Dislocated 14
Device Packaging Compromised 14
Unsealed Device Packaging 14
Entrapment of Device 13
Occlusion Within Device 12
Difficult to Advance 11
Migration or Expulsion of Device 10
Kinked 9

Yearly Trend

92
1992: 27
93
1993: 18
94
1994: 9
95
1995: 1
98
1998: 4
03
2003: 1
04
2004: 2
06
2006: 1
07
2007: 4
08
2008: 24
09
2009: 36
10
2010: 47
11
2011: 49
12
2012: 33
13
2013: 41
14
2014: 48
15
2015: 78
16
2016: 51
17
2017: 29
18
2018: 35
19
2019: 26
20
2020: 14
21
2021: 24
22
2022: 17
23
2023: 12
24
2024: 13
25
2025: 27
26
2026: 6

Reports rose to 27 in 2025, up from an average of 13 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Tube, Drainage, Suprapubic

Top Manufacturers

BOSTON SCIENTIFIC - COSTA RICA (COYOL) 293
BOSTON SCIENTIFIC CORPORATION 199
BOSTON SCIENTIFIC - SPENCER 82
BOSTON SCIENTIFIC 15
UNKNOWN 4
ABBOTT LABORATORIES 3

Event Locations

404 (59.7%)
I 194 (28.7%)
HOSPITAL 67 (9.9%)
INVALID DATA 6 (0.9%)
NO INFORMATION 3 (0.4%)
HOME 2 (0.3%)
OTHER 1 (0.1%)

Compare BOSTON SCIENTIFIC - COSTA RICA (COYOL) vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tube, Drainage, Suprapubic: 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 (677 here).

Stimulator, Muscle, Powered 678 Forceps, General & Plastic Surgery 673 Hearing Aid, Air-Conduction, Prescription 673 Hearing Aid 673

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 Tube, Drainage, Suprapubic 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 Tube, Drainage, Suprapubic; 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.