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2026 data FDA MAUDE openFDA FDA Class II

Lead, Atomic Absorption

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 §862.3550 (Clinical Toxicology panel).

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FDA MAUDE casebook

openFDA event book Lead, Atomic Absorption LIGHT-BOOK · MAUDE

#848 of 1000 · 575 reports · 2004–2026

  • BOOK 575 reports
  • RANK #848 of 1000
  • DEATH 0 death-typed
  • INJ 2 injury-typed
  • MALF 572 malfunction
  • SPAN 2004–2026
  • PEAK 2026: 272
  • PHOTO Pessary, Vaginal

Nearest event-volume peer: Pessary, Vaginal (0 report gap)

Lead, Atomic Absorption sits #848 of 1000 among tracked device types with 575 MAUDE reports spanning 2004–2026. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Lead, Atomic Absorption carries 99.5% MALFUNCTION-coded reports, 34.7pp 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 0.3% corpus 30.3% · below corpus mean (-29.9 pp)
  • MALF 99.5% corpus 64.8% · above corpus mean (+34.7 pp)

Lead product-problem code False Positive Result is 34% of coded problems · Top event location is 62% of location-tagged rows .

Lead, Atomic Absorption in the event-volume neighbourhood

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

reports

What this shows Lead, Atomic Absorption carries 575 MAUDE reports, ranked #848 of 1000.

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

Event Types

Malfunction 572 (99.5%)
Injury 2 (0.3%)
1 (0.2%)

Patient Outcomes

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

Other 287 (50.6%)
277 (48.9%)
Required Intervention 3 (0.5%)

Top Product Problems

False Positive Result 209
Nonstandard Device 97
No Apparent Adverse Event 77
False Negative Result 31
Device Sensing Problem 30
Incorrect, Inadequate or Imprecise Result or Readings 30
Failure to Sense 27
Low Test Results 20
Battery Problem 14
Improper or Incorrect Procedure or Method 13
Corroded 10
Complete Loss of Power 9
Electrical /Electronic Property Problem 9
Failure to Power Up 7
Material Fragmentation 7
Failure to Run on Battery 6
Device Handling Problem 5
Noise, Audible 5
Temperature Problem 5
Use of Device Problem 5

Yearly Trend

04
2004: 1
08
2008: 1
10
2010: 1
13
2013: 1
15
2015: 1
17
2017: 39
18
2018: 40
19
2019: 63
20
2020: 2
21
2021: 98
22
2022: 1
25
2025: 55
26
2026: 272

Reports in 2025 (55) held close to the prior two-year average of 50.

Related Entities for Lead, Atomic Absorption

Event Locations

356 (61.9%)
I 143 (24.9%)
NO INFORMATION 74 (12.9%)
OTHER 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Nationwide devices with a comparable report-volume footprint

Lead, Atomic Absorption 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 (575 here).

Pessary, Vaginal 575 Injector, Contrast Medium, Automatic 576 Sealant, Dural 576 Drug-Eluting Percutaneous Transluminal Coro… 578

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Lead, Atomic Absorption 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 Lead, Atomic Absorption; 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.