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2026 data FDA MAUDE openFDA

Pack, Hot Or Cold, Water Circulating

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.

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FDA MAUDE casebook

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

#662 of 1000 · 983 reports · 1994–2026

  • BOOK 983 reports
  • RANK #662 of 1000
  • DEATH 3 death-typed
  • INJ 498 injury-typed
  • MALF 388 malfunction
  • SPAN 1994–2026
  • PEAK 2011: 241
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous (1 report gap)

Pack, Hot Or Cold, Water Circulating sits #662 of 1000 among tracked device types with 983 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 →

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 (-1.2 pp)
  • INJ 50.7% corpus 30.4% · above corpus mean (+20.2 pp)
  • MALF 39.5% corpus 64.5% · below corpus mean (-25.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 27% of coded problems · Lead manufacturer STRYKER MEDICAL-KALAMAZOO accounts for 100% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .

Pack, Hot Or Cold, Water Circulating 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, Water Circulating carries 983 MAUDE reports, ranked #662 of 1000.

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

Event Types

Injury 498 (50.7%)
Malfunction 388 (39.5%)
49 (5.0%)
Other 45 (4.6%)
Death 3 (0.3%)

Patient Outcomes

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

401 (38.7%)
Other 282 (27.2%)
Disability 193 (18.6%)
Required Intervention 69 (6.7%)
Hospitalization 32 (3.1%)
R 26 (2.5%)
S 16 (1.5%)
O 6 (0.6%)
Life Threatening 5 (0.5%)
Death 4 (0.4%)
L 3 (0.3%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 56
Fluid/Blood Leak 42
Leak/Splash 29
Insufficient Information 13
Device Operates Differently Than Expected 10
Patient Device Interaction Problem 7
Break 6
Improper or Incorrect Procedure or Method 5
Overheating of Device 5
Patient-Device Incompatibility 5
Temperature Problem 5
Excessive Heating 4
Hole In Material 4
Appropriate Term/Code Not Available 3
Device Contamination with Chemical or Other Material 3
Improper Flow or Infusion 3
Electrical /Electronic Property Problem 2
Incorrect, Inadequate or Imprecise Result or Readings 2
Material Separation 2
Mechanical Problem 2

Yearly Trend

94
1994: 3
95
1995: 2
96
1996: 9
97
1997: 13
98
1998: 8
99
1999: 2
00
2000: 3
01
2001: 2
02
2002: 3
03
2003: 3
04
2004: 5
05
2005: 15
06
2006: 6
07
2007: 14
08
2008: 12
09
2009: 17
10
2010: 171
11
2011: 241
12
2012: 65
13
2013: 60
14
2014: 49
15
2015: 60
16
2016: 44
17
2017: 43
18
2018: 40
19
2019: 29
20
2020: 7
21
2021: 14
22
2022: 10
23
2023: 12
24
2024: 10
25
2025: 9
26
2026: 2

Related Entities for Pack, Hot Or Cold, Water Circulating

Top Manufacturers

STRYKER MEDICAL-KALAMAZOO 200

Event Locations

682 (69.4%)
I 160 (16.3%)
HOSPITAL 97 (9.9%)
HOME 14 (1.4%)
NO INFORMATION 12 (1.2%)
OTHER 6 (0.6%)
AMBULATORY SURGICAL FACILITY 4 (0.4%)
INVALID DATA 4 (0.4%)
UNKNOWN 2 (0.2%)
NOT APPLICABLE 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pack, Hot Or Cold, Water Circulating, 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 (983 here).

Prosthesis 984 Stent, Metallic, Expandable, Duodenal 984 Container, Sharps 977 Filter, Bacterial, Breathing-Circuit 977

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

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