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2026 data FDA MAUDE openFDA

System/Device, Pharmacy Compounding

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.

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FDA MAUDE casebook

openFDA event book System/Device, Pharmacy Compounding LIGHT-BOOK · MAUDE

#607 of 1000 · 1,201 reports · 2002–2026

  • BOOK 1,201 reports
  • RANK #607 of 1000
  • DEATH 7 death-typed
  • INJ 41 injury-typed
  • MALF 1,112 malfunction
  • SPAN 2002–2026
  • PEAK 2012: 257
  • PHOTO Accessories

Nearest event-volume peer: Accessories, Blood Circuit, Hemodialysis (2 report gap)

System/Device, Pharmacy Compounding sits #607 of 1000 among tracked device types with 1,201 MAUDE reports spanning 2002–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 3.4% corpus 30.4% · below corpus mean (-27.0 pp)
  • MALF 92.6% corpus 64.5% · above corpus mean (+28.1 pp)

Lead product-problem code Fluid/Blood Leak is 18% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 51% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

System/Device, Pharmacy Compounding in the event-volume neighbourhood

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

reports

What this shows System/Device, Pharmacy Compounding carries 1,201 MAUDE reports, ranked #607 of 1000.

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

Event Types

Malfunction 1,112 (92.6%)
Injury 41 (3.4%)
29 (2.4%)
Other 12 (1.0%)
Death 7 (0.6%)

Patient Outcomes

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

1,003 (82.5%)
Other 153 (12.6%)
Required Intervention 15 (1.2%)
R 11 (0.9%)
Life Threatening 11 (0.9%)
L 6 (0.5%)
Death 6 (0.5%)
Hospitalization 6 (0.5%)
Disability 4 (0.3%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Fluid/Blood Leak 159
Break 132
Leak/Splash 102
Mechanical Problem 83
Application Program Problem: Dose Calculation Error 56
Output Problem 41
Disconnection 40
Incorrect, Inadequate or Imprecise Result or Readings 39
Application Program Problem 33
Product Quality Problem 27
Inadequate User Interface 25
Device Contamination with Chemical or Other Material 22
Failure to Align 18
Improper or Incorrect Procedure or Method 16
Use of Device Problem 15
Component Missing 13
Crack 12
Defective Component 11
Contamination 10
Difficult to Open or Close 10

Yearly Trend

02
2002: 1
04
2004: 2
05
2005: 2
08
2008: 4
09
2009: 4
10
2010: 17
11
2011: 121
12
2012: 257
13
2013: 28
14
2014: 7
15
2015: 39
16
2016: 32
17
2017: 27
18
2018: 65
19
2019: 137
20
2020: 80
21
2021: 130
22
2022: 77
23
2023: 91
24
2024: 46
25
2025: 29
26
2026: 5

Related Entities for System/Device, Pharmacy Compounding

Top Manufacturers

BAXTER HEALTHCARE CORPORATION 336
BAXTER HEALTHCARE 124
BAXTER HEALTHCARE - LARGO 96
B. BRAUN MEDICAL INC. 53
B. BRAUN MEDICAL INC 45

Event Locations

738 (61.4%)
I 413 (34.4%)
NO INFORMATION 27 (2.2%)
HOSPITAL 22 (1.8%)
HOME 1 (0.1%)

Compare BAXTER HEALTHCARE CORPORATION vs BAXTER HEALTHCARE →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System/Device, Pharmacy Compounding, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,201 here).

Accessories, Blood Circuit, Hemodialysis 1,203 Tube, Feeding 1,203 Tube, Gastro-Enterostomy 1,198 System, X-Ray, Stationary 1,197

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Warming. Blood And Plasma 7 Dressing, Wound, Occlusive 7 Image-Intensified Fluoroscopic X-Ray System 7 Instrument 7

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

Disclaimer: MAUDE figures for System/Device, Pharmacy Compounding 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 System/Device, Pharmacy Compounding; 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.