Infant Heel Warmer (Chemical Heat Pack)
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 Infant Heel Warmer LIGHT-BOOK · MAUDE
#922 of 1000 · 466 reports · 1996–2026
- BOOK 466 reports
- RANK #922 of 1000
- DEATH 0 death-typed
- INJ 57 injury-typed
- MALF 393 malfunction
- SPAN 1996–2026
- PEAK 2023: 74
- PHOTO Connector, Airway
Nearest event-volume peer: Connector, Airway (Extension) (0 report gap)
Infant Heel Warmer (Chemical Heat Pack) sits #922 of 1000 among tracked device types with 466 MAUDE reports spanning 1996–2026. 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 run above the device-type norm
Infant Heel Warmer carries 84.3% MALFUNCTION-coded reports, 19.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 12.2% corpus 30.3% · below corpus mean (-18.1 pp)
- MALF 84.3% corpus 64.8% · above corpus mean (+19.5 pp)
Lead product-problem code Burst Container or Vessel is 52% of coded problems · Lead manufacturer COVIDIEN accounts for 79% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .
Infant Heel Warmer in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Clip
Clip, Hemostatic
468 reports
- Laparoscope
Laparoscope, General & Plastic Surgery, Reprocessed
468 reports
- Injector
Injector, Fluid, Non-Electrically Powered
467 reports
- Test
Test, Natriuretic Peptide
467 reports
- Infant Heel W… (this)
Infant Heel Warmer (Chemical Heat Pack)
466 reports
- Connector
Connector, Airway (Extension)
466 reports
What this shows Infant Heel Warmer (Chemical Heat Pack) carries 466 MAUDE reports, ranked #922 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 15 in 2025, down from an average of 50 in the two years before.
Related Entities for Infant Heel Warmer (Chemical Heat Pack)
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Infant Heel Warmer carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (466 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Infant Heel Warmer 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 Infant Heel Warmer; 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.