TOSOH CORPORATION

FDA MAUDE device safety record · 1994–2021

What the Data Shows About TOSOH CORPORATION

TOSOH CORPORATION is associated with 4,787 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1994 through 2021. Of the total, 0 are coded as death reports and 14 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 13 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for TOSOH CORPORATION 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 4,772 reports (99.7% of total). Patient-outcome categorizations are reported across 9 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 10 years of MAUDE data, with the peak single-year volume reaching 3,782 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.

4,787
Total Reports
0
Death Reports
14
Injury Reports
13
Device Types

Event Types

Malfunction 4,772 (99.7%)
Injury 14 (0.3%)
Other 1 (0.0%)

Patient Outcomes

4,641 (96.3%)
Death 53 (1.1%)
Congenital Anomaly 42 (0.9%)
D 32 (0.7%)
Disability 17 (0.4%)
Other 16 (0.3%)
Required Intervention 12 (0.2%)
Hospitalization 4 (0.1%)
O 1 (0.0%)

Yearly Trend

94
1994: 1
04
2004: 1
05
2005: 2
15
2015: 3
16
2016: 7
17
2017: 171
18
2018: 3,782
19
2019: 469
20
2020: 235
21
2021: 116

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.