PlainHospital
2026 data FDA MAUDE openFDA

Pack, Hot Or Cold, Disposable

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Pack, Hot Or Cold, Disposable LIGHT-BOOK · MAUDE

#341 of 1000 · 4,263 reports · 1993–2026

  • BOOK 4,263 reports
  • RANK #341 of 1000
  • DEATH 11 death-typed
  • INJ 2,195 injury-typed
  • MALF 910 malfunction
  • SPAN 1993–2026
  • PEAK 2008: 804
  • PHOTO Battery

Nearest event-volume peer: Battery, Replacement, Rechargeable (12 report gap)

Pack, Hot Or Cold, Disposable sits #341 of 1000 among tracked device types with 4,263 MAUDE reports spanning 1993–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 51.5% corpus 30.4% · above corpus mean (+21.1 pp)
  • MALF 21.3% corpus 64.5% · below corpus mean (-43.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer CARDINAL HEALTH accounts for 53% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Pack, Hot Or Cold, Disposable in the event-volume neighbourhood

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

reports

What this shows Pack, Hot Or Cold, Disposable carries 4,263 MAUDE reports, ranked #341 of 1000.

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

Event Types

Injury 2,195 (51.5%)
Other 1,106 (25.9%)
Malfunction 910 (21.3%)
41 (1.0%)
Death 11 (0.3%)

Patient Outcomes

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

Required Intervention 1,723 (37.9%)
1,538 (33.8%)
Other 830 (18.2%)
R 230 (5.1%)
Hospitalization 132 (2.9%)
S 28 (0.6%)
Disability 24 (0.5%)
O 22 (0.5%)
Death 10 (0.2%)
H 7 (0.2%)
Life Threatening 4 (0.1%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 630
Insufficient Information 339
Use of Device Problem 237
Improper or Incorrect Procedure or Method 220
Leak/Splash 217
Burst Container or Vessel 208
Overheating of Device 100
Patient-Device Incompatibility 99
Break 88
Excessive Heating 81
Temperature Problem 75
Nonstandard Device 55
Fluid/Blood Leak 44
Device Operates Differently Than Expected 42
Material Rupture 41
Unintended Ejection 40
Defective Device 38
Appropriate Term/Code Not Available 33
Explosion 31
Insufficient Heating 30

Yearly Trend

93
1993: 3
94
1994: 6
95
1995: 8
96
1996: 9
97
1997: 8
98
1998: 12
99
1999: 4
00
2000: 22
01
2001: 21
02
2002: 22
03
2003: 29
04
2004: 36
05
2005: 49
06
2006: 52
07
2007: 211
08
2008: 804
09
2009: 210
10
2010: 58
11
2011: 70
12
2012: 53
13
2013: 40
14
2014: 33
15
2015: 193
16
2016: 213
17
2017: 234
18
2018: 262
19
2019: 632
20
2020: 248
21
2021: 142
22
2022: 202
23
2023: 184
24
2024: 112
25
2025: 66
26
2026: 15

Related Entities for Pack, Hot Or Cold, Disposable

Top Manufacturers

CARDINAL HEALTH 111
BECTON DICKINSON 98

Event Locations

2,058 (48.3%)
I 1,655 (38.8%)
HOSPITAL 315 (7.4%)
HOME 94 (2.2%)
NO INFORMATION 66 (1.5%)
OTHER 26 (0.6%)
UNKNOWN 22 (0.5%)
OUTPATIENT TREATMENT FACILITY 12 (0.3%)
INVALID DATA 7 (0.2%)
NURSING HOME 4 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare CARDINAL HEALTH vs BECTON DICKINSON →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pack, Hot Or Cold, Disposable, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (4,263 here).

Battery, Replacement, Rechargeable 4,251 Pump 4,251 System, Hypothermia, Intravenous, Cooling 4,279 Implant, Eye Valve 4,290

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Bariatric Bed 11 Circuit, Breathing 11 Condenser, Heat And Moisture 11 Heater 11

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

Disclaimer: MAUDE figures for Pack, Hot Or Cold, Disposable 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 Pack, Hot Or Cold, Disposable; 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.