Protector, 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 Protector, Ostomy MID-BOOK · MAUDE
#104 of 1000 · 32,254 reports · 2000–2026
- BOOK 32,254 reports
- RANK #104 of 1000
- DEATH 1 death-typed
- INJ 2,008 injury-typed
- MALF 30,237 malfunction
- SPAN 2000–2026
- PEAK 2019: 16,647
- PHOTO Monitor
Nearest event-volume peer: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (26 report gap)
Protector, Ostomy sits #104 of 1000 among tracked device types with 32,254 MAUDE reports spanning 2000–2026. 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
Protector, Ostomy carries 93.7% MALFUNCTION-coded reports, 28.9pp 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 6.2% corpus 30.3% · below corpus mean (-24.1 pp)
- MALF 93.7% corpus 64.8% · above corpus mean (+28.9 pp)
Lead product-problem code Malposition of Device is 84% of coded problems · Lead manufacturer CONVATEC DOMINICAN REPUBLIC INC accounts for 100% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .
Protector, Ostomy in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Detector And…
Detector And Alarm, Arrhythmia
33,370 reports
- Pump
Pump, Infusion, Pca
32,663 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
32,652 reports
- Protector (this)
Protector, Ostomy
32,254 reports
- Monitor
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
32,228 reports
- Bronchoscope
Bronchoscope (Flexible Or Rigid)
31,113 reports
What this shows Protector, Ostomy carries 32,254 MAUDE reports, ranked #104 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (321) held close to the prior two-year average of 328.
Related Entities for Protector, Ostomy
Top Manufacturers
Event Locations
Compare CONVATEC DOMINICAN REPUBLIC INC vs CONVATEC DOMINICAN REPUBLIC, INC. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Protector, 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 (32,254 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Protector, 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 Protector, 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.