ABBVIE - MEDICAL DEVICE CENTER

FDA MAUDE device safety record · 2015–2026

What the Data Shows About ABBVIE - MEDICAL DEVICE CENTER

ABBVIE - MEDICAL DEVICE CENTER is associated with 6,315 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2015 through 2026. Of the total, 147 are coded as death reports and 6,167 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 1 distinct device type attributed to this manufacturer in MAUDE, which means any safety read for ABBVIE - MEDICAL DEVICE CENTER should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Injury at 6,167 reports (97.7% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 12 years of MAUDE data, with the peak single-year volume reaching 952 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

6,315
Total Reports
147
Death Reports
6,167
Injury Reports
1
Device Types

Event Types

Injury 6,167 (97.7%)
Death 147 (2.3%)
Malfunction 1 (0.0%)

Patient Outcomes

Required Intervention 4,994 (65.2%)
Hospitalization 1,093 (14.3%)
R 1,057 (13.8%)
H 228 (3.0%)
Other 180 (2.4%)
O 60 (0.8%)
Death 17 (0.2%)
15 (0.2%)
L 5 (0.1%)
Life Threatening 4 (0.1%)
S 2 (0.0%)
Congenital Anomaly 2 (0.0%)
D 1 (0.0%)

Devices (1)

Yearly Trend

15
2015: 57
16
2016: 174
17
2017: 469
18
2018: 700
19
2019: 952
20
2020: 846
21
2021: 875
22
2022: 591
23
2023: 658
24
2024: 468
25
2025: 474
26
2026: 51

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.