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.
FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §890.5710 (Physical Medicine panel).
FDA MAUDE casebook
openFDA event book Pack, Hot Or Cold, Disposable LIGHT-BOOK · MAUDE
#341 of 1000 · 4,404 reports · 1993–2026
- BOOK 4,404 reports
- RANK #341 of 1000
- DEATH 11 death-typed
- INJ 2,227 injury-typed
- MALF 1,019 malfunction
- SPAN 1993–2026
- PEAK 2008: 804
- PHOTO Orthosis
Nearest event-volume peer: Orthosis, Spondylolisthesis Spinal Fixation (12 report gap)
Pack, Hot Or Cold, Disposable sits #341 of 1000 among tracked device types with 4,404 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 →
Malfunction reports sit below the device-type norm
Pack, Hot Or Cold, Disposable carries 23.1% MALFUNCTION-coded reports, 41.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 50.6% corpus 30.3% · above corpus mean (+20.3 pp)
- MALF 23.1% corpus 64.8% · below corpus mean (-41.7 pp)
Lead product-problem code Unknown (for use when the device problem is not known) is 21% of coded problems · Lead manufacturer CARDINAL HEALTH accounts for 40% of manufacturer-tagged reports · Top event location is 50% 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
- Computer
Computer, Diagnostic, Programmable
4,441 reports
- Pack (this)
Pack, Hot Or Cold, Disposable
4,404 reports
- Orthosis
Orthosis, Spondylolisthesis Spinal Fixation
4,392 reports
- System
System, Hypothermia, Intravenous, Cooling
4,389 reports
- Intestinal St…
Intestinal Stimulator
4,382 reports
- Implant
Implant, Eye Valve
4,379 reports
What this shows Pack, Hot Or Cold, Disposable carries 4,404 MAUDE reports, ranked #341 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports fell to 66 in 2025, down from an average of 148 in the two years before.
Related Entities for Pack, Hot Or Cold, Disposable
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Pack, Hot Or Cold, Disposable: 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 (4,404 here).
Similar death-typed counts
Nearest other device types by death-typed report count (11 here), distinct from the volume row.
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.