PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Applicator, Absorbent Tipped, Non-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, Non-Sterile LIGHT-BOOK · MAUDE

#859 of 1000 · 552 reports · 1994–2026

  • BOOK 552 reports
  • RANK #859 of 1000
  • DEATH 6 death-typed
  • INJ 189 injury-typed
  • MALF 304 malfunction
  • SPAN 1994–2026
  • PEAK 2021: 134
  • PHOTO Cup, Menstrual

Nearest event-volume peer: Cup, Menstrual (1 report gap)

Applicator, Absorbent Tipped, Non-Sterile sits #859 of 1000 among tracked device types with 552 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

Applicator, Absorbent Tipped, Non-Sterile carries 55.1% MALFUNCTION-coded reports, 9.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 34.2% corpus 30.3% · above corpus mean (+3.9 pp)
  • MALF 55.1% corpus 64.8% · below corpus mean (-9.8 pp)

Lead product-problem code Break is 15% of coded problems · Lead manufacturer CAREFUSION, INC accounts for 64% of manufacturer-tagged reports · Top event location I is 35% of location-tagged rows .

Applicator, Absorbent Tipped, Non-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, Non-Sterile carries 552 MAUDE reports, ranked #859 of 1000.

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

Event Types

Malfunction 304 (55.1%)
Injury 189 (34.2%)
Other 28 (5.1%)
25 (4.5%)
Death 6 (1.1%)

Patient Outcomes

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

218 (38.4%)
Other 210 (37.0%)
Required Intervention 100 (17.6%)
Hospitalization 10 (1.8%)
R 9 (1.6%)
Death 6 (1.1%)
O 3 (0.5%)
S 3 (0.5%)
Disability 3 (0.5%)
Life Threatening 3 (0.5%)
L 1 (0.2%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Break 82
Adverse Event Without Identified Device or Use Problem 72
Detachment Of Device Component 70
Contamination /Decontamination Problem 62
Material Separation 50
Use of Device Problem 31
Source, detachment from 20
Defective Device 19
Unraveled Material 17
Contamination 16
Detachment of Device or Device Component 15
Component Falling 12
Defective Component 12
Insufficient Device Problem Information 12
Manufacturing, Packaging or Shipping Problem 10
Device, removal of (non-implant) 9
Unknown (for use when the device problem is not known) 9
Device Markings/Labelling Problem 8
Difficult to Remove 8
Material Fragmentation 7

Yearly Trend

94
1994: 1
95
1995: 2
96
1996: 16
97
1997: 29
98
1998: 4
99
1999: 3
00
2000: 7
01
2001: 2
02
2002: 2
03
2003: 3
05
2005: 1
06
2006: 7
07
2007: 11
08
2008: 13
09
2009: 7
10
2010: 15
11
2011: 42
12
2012: 37
13
2013: 34
14
2014: 14
15
2015: 6
16
2016: 11
17
2017: 18
18
2018: 9
19
2019: 10
20
2020: 64
21
2021: 134
22
2022: 13
23
2023: 9
24
2024: 5
25
2025: 5
26
2026: 18

Reports in 2025 (5) held close to the prior two-year average of 7.

Related Entities for Applicator, Absorbent Tipped, Non-Sterile

Top Manufacturers

CAREFUSION, INC 108
CAREFUSION 23
COVIDIEN 23
MEDLINE INDUSTRIES, LP 14

Event Locations

I 191 (34.6%)
157 (28.4%)
HOSPITAL 108 (19.6%)
HOME 42 (7.6%)
NO INFORMATION 25 (4.5%)
INVALID DATA 13 (2.4%)
OUTPATIENT TREATMENT FACILITY 8 (1.4%)
NURSING HOME 2 (0.4%)
OTHER 2 (0.4%)
UNKNOWN 2 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
NOT APPLICABLE 1 (0.2%)

Compare CAREFUSION, INC vs CAREFUSION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Applicator, Absorbent Tipped, Non-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 (552 here).

Cup, Menstrual 553 Chair, Positioning, Electric 554 Kit, Surgical Instrument, Disposable 550 Prosthesis 555

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Cable, Electrode 6 Catheter, Straight 6 Dilator, Catheter, Ureteral 6 Dressing, Wound, Hydrophilic 6

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

Disclaimer: MAUDE figures for Applicator, Absorbent Tipped, Non-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, Non-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.