2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Gauze/Sponge, Internal, X-Ray Detectable LIGHT-BOOK · MAUDE

#438 of 1000 · 2,473 reports · 1992–2026

  • BOOK 2,473 reports
  • RANK #438 of 1000
  • DEATH 3 death-typed
  • INJ 194 injury-typed
  • MALF 2,149 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 291
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer (15 report gap)

Gauze/Sponge, Internal, X-Ray Detectable sits #438 of 1000 among tracked device types with 2,473 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 7.8% corpus 30.4% · below corpus mean (-22.6 pp)
  • MALF 86.9% corpus 64.5% · above corpus mean (+22.4 pp)

Lead product-problem code Material Frayed is 21% of coded problems · Lead manufacturer COVIDIEN accounts for 72% of manufacturer-tagged reports · Top event location I is 46% 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

reports

What this shows Gauze/Sponge, Internal, X-Ray Detectable carries 2,473 MAUDE reports, ranked #438 of 1000.

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

Event Types

Malfunction 2,149 (86.9%)
Injury 194 (7.8%)
Other 81 (3.3%)
46 (1.9%)
Death 3 (0.1%)

Patient Outcomes

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

2,108 (84.0%)
Other 204 (8.1%)
Required Intervention 126 (5.0%)
R 25 (1.0%)
Hospitalization 24 (1.0%)
O 8 (0.3%)
H 4 (0.2%)
Life Threatening 4 (0.2%)
L 2 (0.1%)
Death 2 (0.1%)
Disability 1 (0.0%)
Not Applicable 1 (0.0%)

Top Product Problems

Material Frayed 364
Material Fragmentation 361
Detachment of Device or Device Component 239
Material Separation 114
Component Missing 98
Material Integrity Problem 92
Incomplete or Missing Packaging 89
Packaging Problem 84
Particulates 55
Detachment Of Device Component 44
Material Disintegration 41
Manufacturing, Packaging or Shipping Problem 32
Device Contamination with Chemical or Other Material 26
Device Packaging Compromised 23
Break 22
Device Misassembled During Manufacturing /Shipping 21
Contamination /Decontamination Problem 17
Unraveled Material 17
Contamination 16
Delivered as Unsterile Product 16

Yearly Trend

92
1992: 3
93
1993: 1
94
1994: 15
95
1995: 6
96
1996: 15
97
1997: 17
98
1998: 12
99
1999: 6
00
2000: 14
01
2001: 16
02
2002: 6
03
2003: 6
04
2004: 18
05
2005: 11
06
2006: 19
07
2007: 15
08
2008: 25
09
2009: 96
10
2010: 44
11
2011: 38
12
2012: 80
13
2013: 40
14
2014: 65
15
2015: 122
16
2016: 291
17
2017: 252
18
2018: 250
19
2019: 177
20
2020: 116
21
2021: 134
22
2022: 226
23
2023: 98
24
2024: 114
25
2025: 115
26
2026: 10

Related Entities for Gauze/Sponge, Internal, X-Ray Detectable

Event Locations

I 1,143 (46.2%)
677 (27.4%)
HOSPITAL 520 (21.0%)
NO INFORMATION 49 (2.0%)
OUTPATIENT TREATMENT FACILITY 32 (1.3%)
OTHER 26 (1.1%)
AMBULATORY SURGICAL FACILITY 19 (0.8%)
INVALID DATA 3 (0.1%)
OPERATING ROOM 2 (0.1%)
HOME 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare COVIDIEN vs STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Gauze/Sponge, Internal, X-Ray Detectable, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,473 here).

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

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.