CONCORD MANUFACTURING

FDA MAUDE device safety record · 2013–2025

What the Data Shows About CONCORD MANUFACTURING

CONCORD MANUFACTURING is associated with 19,792 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2013 through 2025. Of the total, 743 are coded as death reports and 4,220 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 8 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for CONCORD MANUFACTURING 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 Malfunction at 14,829 reports (74.9% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 13 years of MAUDE data, with the peak single-year volume reaching 3,758 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.

19,792
Total Reports
743
Death Reports
4,220
Injury Reports
8
Device Types

Event Types

Malfunction 14,829 (74.9%)
Injury 4,220 (21.3%)
Death 743 (3.8%)

Patient Outcomes

14,929 (66.6%)
Hospitalization 2,297 (10.2%)
R 1,953 (8.7%)
Required Intervention 1,648 (7.3%)
Death 725 (3.2%)
H 447 (2.0%)
L 179 (0.8%)
Other 127 (0.6%)
Life Threatening 46 (0.2%)
D 44 (0.2%)
O 35 (0.2%)
Disability 1 (0.0%)

Yearly Trend

13
2013: 3
14
2014: 51
15
2015: 2
16
2016: 169
17
2017: 1,467
18
2018: 3,758
19
2019: 3,675
20
2020: 2,364
21
2021: 2,533
22
2022: 2,222
23
2023: 1,965
24
2024: 1,570
25
2025: 13

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.