BLUE BELT TECHNOLOGIES

FDA MAUDE device safety record · 2014–2026

What the Data Shows About BLUE BELT TECHNOLOGIES

BLUE BELT TECHNOLOGIES is associated with 4,628 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2014 through 2026. Of the total, 0 are coded as death reports and 1,358 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 7 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for BLUE BELT TECHNOLOGIES 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 3,269 reports (70.6% of total). Patient-outcome categorizations are reported across 10 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 2,107 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.

4,628
Total Reports
0
Death Reports
1,358
Injury Reports
7
Device Types

Event Types

Malfunction 3,269 (70.6%)
Injury 1,358 (29.3%)
Other 1 (0.0%)

Patient Outcomes

3,244 (66.0%)
Required Intervention 905 (18.4%)
Other 322 (6.6%)
R 218 (4.4%)
Hospitalization 145 (3.0%)
O 55 (1.1%)
H 17 (0.3%)
Disability 7 (0.1%)
Congenital Anomaly 1 (0.0%)
Life Threatening 1 (0.0%)

Yearly Trend

14
2014: 1
15
2015: 2
16
2016: 4
17
2017: 6
18
2018: 1
19
2019: 54
20
2020: 2,107
21
2021: 918
22
2022: 690
23
2023: 246
24
2024: 271
25
2025: 286
26
2026: 42

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.