2026 data FDA MAUDE openFDA FDA Class I

Collector, Ostomy

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 §876.5900 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Collector, Ostomy LIGHT-BOOK · MAUDE

#863 of 1000 · 543 reports · 1998–2026

  • BOOK 543 reports
  • RANK #863 of 1000
  • DEATH 2 death-typed
  • INJ 489 injury-typed
  • MALF 43 malfunction
  • SPAN 1998–2026
  • PEAK 2013: 187
  • PHOTO Insufflator

Nearest event-volume peer: Insufflator, Hysteroscopic (2 report gap)

Collector, Ostomy sits #863 of 1000 among tracked device types with 543 MAUDE reports spanning 1998–2026. 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

Collector, Ostomy carries 90.1% INJURY-coded reports, 59.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 90.1% corpus 30.3% · above corpus mean (+59.8 pp)
  • MALF 7.9% corpus 64.8% · below corpus mean (-56.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Lead manufacturer CONVATEC DOMINICAN REPUBLIC, INC. accounts for 46% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Collector, Ostomy in the event-volume neighbourhood

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

reports

What this shows Collector, Ostomy carries 543 MAUDE reports, ranked #863 of 1000.

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

Event Types

Injury 489 (90.1%)
Malfunction 43 (7.9%)
Other 5 (0.9%)
4 (0.7%)
Death 2 (0.4%)

Patient Outcomes

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

Required Intervention 341 (61.3%)
127 (22.8%)
Other 47 (8.5%)
Hospitalization 19 (3.4%)
R 9 (1.6%)
Life Threatening 6 (1.1%)
H 2 (0.4%)
O 2 (0.4%)
Death 2 (0.4%)
Disability 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 181
Insufficient Device Problem Information 168
Patient-Device Incompatibility 51
Device Operates Differently Than Expected 27
Leak/Splash 21
Fluid/Blood Leak 12
Human-Device Interface Problem 12
Malposition of Device 9
Loss of or Failure to Bond 8
Improper or Incorrect Procedure or Method 7
Inadequacy of Device Shape and/or Size 7
Biocompatibility 5
Detachment Of Device Component 5
Failure To Adhere Or Bond 5
Break 4
Defective Device 4
Patient Device Interaction Problem 4
Use of Device Problem 4
Lack of Effect 3
No Flow 3

Yearly Trend

98
1998: 1
99
1999: 1
04
2004: 2
05
2005: 3
08
2008: 1
09
2009: 1
10
2010: 5
11
2011: 4
12
2012: 7
13
2013: 187
14
2014: 55
15
2015: 6
16
2016: 20
17
2017: 20
18
2018: 36
19
2019: 34
20
2020: 22
21
2021: 42
22
2022: 36
23
2023: 11
24
2024: 13
25
2025: 21
26
2026: 15

Reports rose to 21 in 2025, up from an average of 12 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Collector, Ostomy

Event Locations

332 (61.1%)
I 153 (28.2%)
HOME 39 (7.2%)
NO INFORMATION 11 (2.0%)
HOSPITAL 7 (1.3%)
OTHER 1 (0.2%)

Compare CONVATEC DOMINICAN REPUBLIC, INC. vs COLOPLAST A/S →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Collector, Ostomy: 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 (543 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Collector, Ostomy 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 Collector, Ostomy; 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.