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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §890.5720 (Physical Medicine panel).

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FDA MAUDE casebook

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

#667 of 1000 · 984 reports · 1994–2026

  • BOOK 984 reports
  • RANK #667 of 1000
  • DEATH 3 death-typed
  • INJ 499 injury-typed
  • MALF 388 malfunction
  • SPAN 1994–2026
  • PEAK 2011: 241
  • PHOTO Midline Catheter

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

Pack, Hot Or Cold, Water Circulating sits #667 of 1000 among tracked device types with 984 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

Pack, Hot Or Cold, Water Circulating carries 39.4% MALFUNCTION-coded reports, 25.4pp 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 50.7% corpus 30.3% · above corpus mean (+20.4 pp)
  • MALF 39.4% corpus 64.8% · below corpus mean (-25.4 pp)

Lead product-problem code Insufficient Device Problem Information is 42% 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 984 MAUDE reports, ranked #667 of 1000.

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

Event Types

Injury 499 (50.7%)
Malfunction 388 (39.4%)
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

Insufficient Device Problem Information 388
Adverse Event Without Identified Device or Use Problem 75
Fluid/Blood Leak 68
Leak/Splash 60
Device Operates Differently Than Expected 49
Break 48
Overheating of Device 44
Unknown (for use when the device problem is not known) 37
Scratched Material 32
Improper or Incorrect Procedure or Method 20
Crack 17
Temperature Problem 16
Use of Device Problem 15
Moisture Damage 14
Thermal Decomposition of Device 11
Hole In Material 8
Patient Device Interaction Problem 8
Replace 7
Melted 6
Insufficient Cooling 5

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: 3

Reports in 2025 (9) held close to the prior two-year average of 11.

Related Entities for Pack, Hot Or Cold, Water Circulating

Top Manufacturers

STRYKER MEDICAL-KALAMAZOO 200

Event Locations

683 (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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pack, Hot Or Cold, Water Circulating: 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 (984 here).

Midline Catheter 983 Hepatitis A Test 982 Single-Use Reprocessed Ultrasonic Surgical… 980 Container, Sharps 979

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.