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2026 data FDA MAUDE openFDA FDA Class II

Mask, Surgical

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 II (moderate risk, special controls required), regulated under 21 CFR §878.4040 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Mask, Surgical LIGHT-BOOK · MAUDE

#870 of 1000 · 534 reports · 1994–2026

  • BOOK 534 reports
  • RANK #870 of 1000
  • DEATH 0 death-typed
  • INJ 257 injury-typed
  • MALF 188 malfunction
  • SPAN 1994–2026
  • PEAK 2021: 67
  • PHOTO Culture Media

Nearest event-volume peer: Culture Media, Selective And Non-Differential (0 report gap)

Mask, Surgical sits #870 of 1000 among tracked device types with 534 MAUDE reports spanning 1994–2026. 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 sit below the device-type norm

Mask, Surgical carries 35.2% MALFUNCTION-coded reports, 29.6pp below 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 48.1% corpus 30.3% · above corpus mean (+17.8 pp)
  • MALF 35.2% corpus 64.8% · below corpus mean (-29.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer UNK accounts for 32% of manufacturer-tagged reports · Top event location is 41% of location-tagged rows .

Mask, Surgical in the event-volume neighbourhood

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

reports

What this shows Mask, Surgical carries 534 MAUDE reports, ranked #870 of 1000.

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

Event Types

Injury 257 (48.1%)
Malfunction 188 (35.2%)
Other 74 (13.9%)
15 (2.8%)

Patient Outcomes

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

Other 260 (46.5%)
193 (34.5%)
Required Intervention 48 (8.6%)
Disability 13 (2.3%)
Hospitalization 10 (1.8%)
R 9 (1.6%)
S 9 (1.6%)
Life Threatening 6 (1.1%)
O 5 (0.9%)
L 3 (0.5%)
Not Applicable 2 (0.4%)
Invalid Data 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 110
Patient-Device Incompatibility 76
Unknown (for use when the device problem is not known) 47
Delivered as Unsterile Product 39
Insufficient Device Problem Information 35
Reaction 21
Break 20
Component Incompatible 15
Product Quality Problem 14
Patient Device Interaction Problem 12
Compatibility Problem 9
Device Emits Odor 8
Material Separation 7
Component Falling 6
Detachment Of Device Component 6
Nonstandard Device 6
Appropriate Device Problem Term/Code Not Available 5
Contamination 5
Defective Device 5
Protective Measures Problem 5

Yearly Trend

94
1994: 5
95
1995: 5
96
1996: 16
97
1997: 43
98
1998: 10
99
1999: 2
00
2000: 3
01
2001: 3
02
2002: 1
03
2003: 3
04
2004: 4
05
2005: 4
06
2006: 12
07
2007: 11
08
2008: 10
09
2009: 3
10
2010: 9
11
2011: 8
12
2012: 22
13
2013: 9
14
2014: 5
15
2015: 14
16
2016: 16
17
2017: 45
18
2018: 21
19
2019: 23
20
2020: 60
21
2021: 67
22
2022: 21
23
2023: 21
24
2024: 21
25
2025: 11
26
2026: 26

Reports fell to 11 in 2025, down from an average of 21 in the two years before.

Related Entities for Mask, Surgical

Top Manufacturers

UNK 42
STRYKER INSTRUMENTS-KALAMAZOO 40
CARDINAL HEALTH 36
MEDLINE INDUSTRIES, LP 13

Event Locations

220 (41.2%)
I 136 (25.5%)
HOSPITAL 79 (14.8%)
NO INFORMATION 71 (13.3%)
OTHER 13 (2.4%)
INVALID DATA 8 (1.5%)
OUTPATIENT TREATMENT FACILITY 2 (0.4%)
UNKNOWN 2 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
HOME 1 (0.2%)
NURSING HOME 1 (0.2%)

Compare UNK vs STRYKER INSTRUMENTS-KALAMAZOO →

Nationwide devices with a comparable report-volume footprint

Mask, Surgical carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (534 here).

Culture Media 534 Accessories, Pump, Infusion 537 Bag, Urinary, Ileostomy 539 Container, Specimen, Sterile 539

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Mask, Surgical 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 Mask, Surgical; 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.