2026 data FDA MAUDE openFDA FDA Class II

Susceptibility Test Powders, Antimycobacterial

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 §866.1640 (Microbiology panel).

FDA MAUDE casebook

openFDA event book Susceptibility Test Powders LIGHT-BOOK · MAUDE

#703 of 1000 · 874 reports · 2021–2026

  • BOOK 874 reports
  • RANK #703 of 1000
  • DEATH 0 death-typed
  • INJ 4 injury-typed
  • MALF 870 malfunction
  • SPAN 2021–2026
  • PEAK 2025: 533
  • PHOTO Stent, Renal

Nearest event-volume peer: Stent, Renal (0 report gap)

Susceptibility Test Powders, Antimycobacterial sits #703 of 1000 among tracked device types with 874 MAUDE reports spanning 2021–2026. 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

Susceptibility Test Powders 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 0.5% corpus 30.3% · below corpus mean (-29.8 pp)
  • MALF 99.5% corpus 64.8% · above corpus mean (+34.7 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 98% of coded problems · Lead manufacturer BECTON DICKINSON & CO. (SPARKS) accounts for 61% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Susceptibility Test Powders in the event-volume neighbourhood

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

reports

What this shows Susceptibility Test Powders, Antimycobacterial carries 874 MAUDE reports, ranked #703 of 1000.

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

Event Types

Malfunction 870 (99.5%)
Injury 4 (0.5%)

Patient Outcomes

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

847 (96.9%)
Other 26 (3.0%)
Required Intervention 1 (0.1%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 838
Contamination 5
False Positive Result 4
Contamination of Device Ingredient or Reagent 2
Device Markings/Labelling Problem 2
Non Reproducible Results 1

Yearly Trend

21
2021: 5
22
2022: 10
23
2023: 43
24
2024: 164
25
2025: 533
26
2026: 119

Reports rose to 533 in 2025, up from an average of 104 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Susceptibility Test Powders, Antimycobacterial

Compare BECTON DICKINSON & CO. (SPARKS) vs BECTON, DICKINSON & CO. (SPARKS) →

Nationwide devices with a comparable report-volume footprint

Susceptibility Test Powders 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 (874 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Susceptibility Test Powders 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 Susceptibility Test Powders; 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.