PlainHospital

ABBOTT MANUFACTURING INC

Manufacturer adverse-event records for ABBOTT MANUFACTURING INC come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1999–2020 · thin-book · typical Death-code · injury-light

Injury-mix signature

ABBOTT MANUFACTURING INC is lighter on Injury codes

Injury-coded event_type share is 2.0% (injury-light tercile) beside 0.11% Death-coded (typical). Volume band: thin.

What the Injury-mix reading shows for ABBOTT MANUFACTURING INC

The standout signal for ABBOTT MANUFACTURING INC is Injury-mix: 2.0% Injury-coded (injury-light) beside 0.11% Death-coded, on a thin-book footprint.

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Malfunction at 5,378 (97.6% of event_type total). Peak single-year volume reaches 2,189 reports across 18 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,511
Total Reports
6
Event-type Death
112
Injury Reports
20
Device Types

Event Types

Malfunction 5,378 (97.6%)
Injury 112 (2.0%)
Other 15 (0.3%)
Death 6 (0.1%)

Patient Outcomes

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

5,341 (96.9%)
Other 73 (1.3%)
Required Intervention 70 (1.3%)
Disability 20 (0.4%)
Death 6 (0.1%)
R 1 (0.0%)
Life Threatening 1 (0.0%)

Devices (20)

Device Reports
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 2,712
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes 1,440
Calculator/Data Processing Module, For Clinical Use 436
Photometric Method, Magnesium 94
Electrode, Ion Specific, Sodium 90
Azo Dye, Calcium 74
Immunoassay Method, Troponin Subunit 70
Urease And Glutamic Dehydrogenase, Urea Nitrogen 69
Alkaline Picrate, Colorimetry, Creatinine 58
Test, Equipment, Automated Bloodborne Pathogen 46
Diazo Colorimetry, Bilirubin 45
Electrode, Ion-Specific, Chloride 38
Enzymatic, Carbon-Dioxide 34
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase 33
Radioimmunoassay, Thyroid-Stimulating Hormone 23
Test, System, Potassium, Enzymatic Method 22
System, Test, Human Chorionic Gonadotropin 21
Colorimeter, Photometer, Spectrophotometer For Clinical Use 20
Hexokinase, Glucose 19
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 17

Yearly Trend

99
1999: 1
00
2000: 5
01
2001: 2
05
2005: 1
06
2006: 3
07
2007: 7
08
2008: 12
10
2010: 4
11
2011: 301
12
2012: 519
13
2013: 368
14
2014: 260
15
2015: 305
16
2016: 281
17
2017: 391
18
2018: 2,189
19
2019: 781
20
2020: 81

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