Gauze/Sponge, Internal, X-Ray Detectable
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 §878.4450 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Gauze/Sponge, Internal, X-Ray Detectable LIGHT-BOOK · MAUDE
#448 of 1000 · 2,521 reports · 1992–2026
- BOOK 2,521 reports
- RANK #448 of 1000
- DEATH 3 death-typed
- INJ 204 injury-typed
- MALF 2,187 malfunction
- SPAN 1992–2026
- PEAK 2016: 291
- PHOTO Prosthesis
Nearest event-volume peer: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer (1 report gap)
Gauze/Sponge, Internal, X-Ray Detectable sits #448 of 1000 among tracked device types with 2,521 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 sit below the device-type norm
Gauze/Sponge, Internal, X-Ray Detectable carries 8.1% INJURY-coded reports, 22.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 8.1% corpus 30.3% · below corpus mean (-22.2 pp)
- MALF 86.8% corpus 64.8% · above corpus mean (+21.9 pp)
Lead product-problem code Material Frayed is 24% of coded problems · Lead manufacturer COVIDIEN accounts for 72% of manufacturer-tagged reports · Top event location I is 45% of location-tagged rows .
Gauze/Sponge, Internal, X-Ray Detectable in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Mattress
Mattress, Air Flotation, Alternating Pressure
2,524 reports
- Gauze/Sponge (this)
Gauze/Sponge, Internal, X-Ray Detectable
2,521 reports
- Prosthesis
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
2,520 reports
- Aid, Transfer
Aid, Transfer
2,515 reports
- Suture
Suture, Absorbable, Natural
2,489 reports
- Tube
Tube, Bronchial (W/Wo Connector)
2,475 reports
What this shows Gauze/Sponge, Internal, X-Ray Detectable carries 2,521 MAUDE reports, ranked #448 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 (115) held close to the prior two-year average of 106.
Related Entities for Gauze/Sponge, Internal, X-Ray Detectable
Top Manufacturers
Event Locations
Compare COVIDIEN vs STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Gauze/Sponge, Internal, X-Ray Detectable: 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 (2,521 here).
Similar death-typed counts
Nearest other device types by death-typed report count (3 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Gauze/Sponge, Internal, X-Ray Detectable 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 Gauze/Sponge, Internal, X-Ray Detectable; 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.