2025 data FDA MAUDE openFDA FDA Class I

Patient Examination Glove

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 §880.6250 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Patient Examination Glove LIGHT-BOOK · MAUDE

#905 of 1000 · 484 reports · 1992–2025

  • BOOK 484 reports
  • RANK #905 of 1000
  • DEATH 1 death-typed
  • INJ 30 injury-typed
  • MALF 431 malfunction
  • SPAN 1992–2025
  • PEAK 2016: 333
  • PHOTO Cane

Nearest event-volume peer: Cane (0 report gap)

Patient Examination Glove sits #905 of 1000 among tracked device types with 484 MAUDE reports spanning 1992–2025. 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

Patient Examination Glove carries 89.0% MALFUNCTION-coded reports, 24.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 6.2% corpus 30.3% · below corpus mean (-24.1 pp)
  • MALF 89.0% corpus 64.8% · above corpus mean (+24.2 pp)

Lead product-problem code Torn Material is 40% of coded problems · Lead manufacturer COVIDIEN accounts for 98% of manufacturer-tagged reports · Top event location I is 81% of location-tagged rows .

Patient Examination Glove in the event-volume neighbourhood

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

reports

What this shows Patient Examination Glove carries 484 MAUDE reports, ranked #905 of 1000.

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

Event Types

Malfunction 431 (89.0%)
Injury 30 (6.2%)
Other 16 (3.3%)
6 (1.2%)
Death 1 (0.2%)

Patient Outcomes

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

443 (91.0%)
Other 32 (6.6%)
Required Intervention 8 (1.6%)
R 1 (0.2%)
S 1 (0.2%)
Hospitalization 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Torn Material 217
Split 95
Crack 41
Material Integrity Problem 38
Break 26
Hole In Material 25
Device Damaged Prior to Use 19
Out-Of-Box Failure 12
Tears, rips, holes in device, device material 10
Adverse Event Without Identified Device or Use Problem 9
Component or Accessory Incompatibility 8
Unknown (for use when the device problem is not known) 7
Contamination 6
Device Operates Differently Than Expected 6
Product Quality Problem 6
Fluid/Blood Leak 5
Foreign material 5
Fitting Problem 4
Nonstandard Device 4
Packaging Problem 4

Yearly Trend

92
1992: 1
94
1994: 5
95
1995: 3
96
1996: 5
97
1997: 1
98
1998: 5
01
2001: 2
02
2002: 2
03
2003: 1
04
2004: 4
06
2006: 6
07
2007: 9
08
2008: 5
09
2009: 3
10
2010: 7
11
2011: 1
12
2012: 2
13
2013: 3
14
2014: 7
15
2015: 41
16
2016: 333
17
2017: 32
19
2019: 1
20
2020: 1
21
2021: 3
25
2025: 1

Reports rose to 3 in 2021, up from an average of 1 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Patient Examination Glove

Event Locations

I 393 (81.2%)
34 (7.0%)
HOSPITAL 30 (6.2%)
OTHER 10 (2.1%)
UNKNOWN 6 (1.2%)
INVALID DATA 4 (0.8%)
NO INFORMATION 4 (0.8%)
HOME 2 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)

Compare COVIDIEN vs BECTON DICKINSON AND CO. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Patient Examination Glove: 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 (484 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Patient Examination Glove 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 Patient Examination Glove; 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.