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2026 data FDA MAUDE openFDA FDA Class II

Indicator, Physical/Chemical Sterilization Process

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 §880.2800 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Indicator LIGHT-BOOK · MAUDE

#983 of 1000 · 386 reports · 1999–2026

  • BOOK 386 reports
  • RANK #983 of 1000
  • DEATH 1 death-typed
  • INJ 15 injury-typed
  • MALF 338 malfunction
  • SPAN 1999–2026
  • PEAK 2003: 60
  • PHOTO Blood Pump For Ecmo

Nearest event-volume peer: Blood Pump For Ecmo, Long-Term (> 6 Hours) Use (0 report gap)

Indicator, Physical/Chemical Sterilization Process sits #983 of 1000 among tracked device types with 386 MAUDE reports spanning 1999–2026. 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

Indicator carries 3.9% INJURY-coded reports, 26.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 3.9% corpus 30.3% · below corpus mean (-26.4 pp)
  • MALF 87.6% corpus 64.8% · above corpus mean (+22.7 pp)

Lead product-problem code Material Integrity Problem is 12% of coded problems · Lead manufacturer ADVANCED STERILIZATION PRODUCTS accounts for 100% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Indicator in the event-volume neighbourhood

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

reports

What this shows Indicator, Physical/Chemical Sterilization Process carries 386 MAUDE reports, ranked #983 of 1000.

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

Event Types

Malfunction 338 (87.6%)
26 (6.7%)
Injury 15 (3.9%)
Other 6 (1.6%)
Death 1 (0.3%)

Patient Outcomes

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

328 (83.7%)
Other 45 (11.5%)
Required Intervention 6 (1.5%)
H 3 (0.8%)
Life Threatening 3 (0.8%)
O 2 (0.5%)
R 2 (0.5%)
Hospitalization 2 (0.5%)
Death 1 (0.3%)

Top Product Problems

Material Integrity Problem 44
Device Operates Differently Than Expected 42
Improper Chemical Reaction 36
False Positive Result 32
Chemical Problem 31
Unexpected Color 24
Leak/Splash 21
False Reading From Device Non-Compliance 18
Fluid/Blood Leak 17
Use of Device Problem 14
Appropriate Device Problem Term/Code Not Available 13
Material Discolored 13
Incorrect Or Inadequate Test Results 9
Insufficient Device Problem Information 9
Other (for use when an appropriate device code cannot be identified) 9
Incorrect, Inadequate or Imprecise Result or Readings 8
Contamination /Decontamination Problem 7
Device Disinfection Or Sterilization Issue 7
Problem with Sterilization 7
Device Expiration Issue 6

Yearly Trend

99
1999: 1
00
2000: 3
01
2001: 2
02
2002: 1
03
2003: 60
04
2004: 4
05
2005: 9
06
2006: 6
07
2007: 1
08
2008: 1
09
2009: 9
10
2010: 3
11
2011: 1
12
2012: 8
13
2013: 6
14
2014: 11
15
2015: 7
16
2016: 11
17
2017: 35
18
2018: 12
19
2019: 8
20
2020: 6
21
2021: 29
22
2022: 23
23
2023: 39
24
2024: 25
25
2025: 12
26
2026: 53

Reports fell to 12 in 2025, down from an average of 32 in the two years before.

Related Entities for Indicator, Physical/Chemical Sterilization Process

Top Manufacturers

ADVANCED STERILIZATION PRODUCTS 45

Event Locations

244 (63.2%)
I 60 (15.5%)
HOSPITAL 56 (14.5%)
NO INFORMATION 18 (4.7%)
OUTPATIENT TREATMENT FACILITY 4 (1.0%)
UNKNOWN 2 (0.5%)
AMBULATORY SURGICAL FACILITY 1 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.3%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Indicator: 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 (386 here).

Blood Pump For Ecmo, Long-Term Use 386 Catheter, Cholangiography 386 Scissors, Ophthalmic 385 Reagent Red Blood Cells 389

Similar death-typed counts

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

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Indicator 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 Indicator; 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.