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2026 data FDA MAUDE openFDA FDA Class I

Applicator, Absorbent Tipped, Sterile

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 §880.6025 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Applicator, Absorbent Tipped, Sterile LIGHT-BOOK · MAUDE

#723 of 1000 · 813 reports · 1992–2026

  • BOOK 813 reports
  • RANK #723 of 1000
  • DEATH 1 death-typed
  • INJ 332 injury-typed
  • MALF 458 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 406
  • PHOTO Catheter, Nephrostomy

Nearest event-volume peer: Catheter, Nephrostomy (1 report gap)

Applicator, Absorbent Tipped, Sterile sits #723 of 1000 among tracked device types with 813 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 run above the device-type norm

Applicator, Absorbent Tipped, Sterile carries 40.8% INJURY-coded reports, 10.5pp above 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 40.8% corpus 30.3% · above corpus mean (+10.5 pp)
  • MALF 56.3% corpus 64.8% · below corpus mean (-8.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 28% of coded problems · Lead manufacturer CAREFUSION, INC accounts for 74% of manufacturer-tagged reports · Top event location I is 56% of location-tagged rows .

Applicator, Absorbent Tipped, Sterile in the event-volume neighbourhood

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

reports

What this shows Applicator, Absorbent Tipped, Sterile carries 813 MAUDE reports, ranked #723 of 1000.

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

Event Types

Malfunction 458 (56.3%)
Injury 332 (40.8%)
Other 20 (2.5%)
2 (0.2%)
Death 1 (0.1%)

Patient Outcomes

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

Other 585 (68.3%)
125 (14.6%)
Required Intervention 78 (9.1%)
R 26 (3.0%)
Hospitalization 15 (1.8%)
O 13 (1.5%)
H 5 (0.6%)
Disability 4 (0.5%)
Death 3 (0.4%)
S 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 224
Contamination /Decontamination Problem 120
Detachment of Device or Device Component 103
Break 64
Defective Device 49
No Apparent Adverse Event 34
Defective Component 32
Manufacturing, Packaging or Shipping Problem 29
Contamination 20
Fracture 19
Detachment Of Device Component 17
Fire 14
Insufficient Device Problem Information 13
Appropriate Device Problem Term/Code Not Available 12
Material Separation 12
Incorrect, Inadequate or Imprecise Result or Readings 11
Premature Separation 11
Material Fragmentation 9
Entrapment of Device 8
Leak/Splash 8

Yearly Trend

92
1992: 1
93
1993: 1
96
1996: 1
97
1997: 10
98
1998: 2
00
2000: 2
02
2002: 3
03
2003: 12
04
2004: 5
05
2005: 7
06
2006: 7
07
2007: 4
08
2008: 1
09
2009: 1
10
2010: 3
11
2011: 5
12
2012: 4
13
2013: 8
14
2014: 11
15
2015: 10
16
2016: 10
17
2017: 1
18
2018: 5
19
2019: 7
20
2020: 160
21
2021: 406
22
2022: 65
23
2023: 33
24
2024: 10
25
2025: 15
26
2026: 3

Reports in 2025 (15) held close to the prior two-year average of 22.

Related Entities for Applicator, Absorbent Tipped, Sterile

Top Manufacturers

CAREFUSION, INC 172
UNK 28
CARDINAL HEALTH 21
BECTON DICKINSON & CO. (SPARKS) 11

Event Locations

I 452 (55.6%)
211 (26.0%)
HOSPITAL 51 (6.3%)
NO INFORMATION 51 (6.3%)
OTHER 25 (3.1%)
HOME 10 (1.2%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.6%)
OUTPATIENT TREATMENT FACILITY 4 (0.5%)
UNKNOWN 2 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
HOSPICE 1 (0.1%)

Compare CAREFUSION, INC vs UNK →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Applicator, Absorbent Tipped, Sterile: 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 (813 here).

Catheter, Nephrostomy 812 Lithotriptor 811 Bed, Patient Rotation, Powered 817 Respiratory Virus Panel Nucleic Acid Assay… 808

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 Applicator, Absorbent Tipped, Sterile 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 Applicator, Absorbent Tipped, Sterile; 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.