BIOSENSE WEBSTER, INC. (JUAREZ)

Manufacturer adverse-event records for BIOSENSE WEBSTER, 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 · 2007–2017 · thin-book · elevated Death-code · injury-heavy

Death-code intensity

BIOSENSE WEBSTER, INC. carries an elevated Death-code share

Death-coded event_type rows are 163 of 4,437 (3.67% · elevated tercile among 443 manufacturers). Absolute volume is thin-book.

What the Death-code reading shows for BIOSENSE WEBSTER, INC. (JUAREZ)

The standout signal for BIOSENSE WEBSTER, INC. (JUAREZ) is Death-code intensity: 3.67% of 4,437 reports (elevated tercile), while absolute volume is thin-book.

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 10 device types, led in this extract by Injury at 2,651 (59.7% of event_type total). Peak single-year volume reaches 973 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,437
Total Reports
163
Event-type Death
2,651
Injury Reports
10
Device Types

Event Types

Injury 2,651 (59.7%)
Malfunction 1,618 (36.5%)
Death 163 (3.7%)
5 (0.1%)

Patient Outcomes

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

R 2,083 (26.7%)
1,626 (20.9%)
Hospitalization 1,280 (16.4%)
L 1,116 (14.3%)
Life Threatening 965 (12.4%)
Other 277 (3.6%)
Death 175 (2.2%)
Required Intervention 113 (1.5%)
O 111 (1.4%)
H 33 (0.4%)
S 9 (0.1%)
Disability 1 (0.0%)

Yearly Trend

07
2007: 10
08
2008: 51
09
2009: 56
10
2010: 90
11
2011: 138
12
2012: 389
13
2013: 469
14
2014: 643
15
2015: 973
16
2016: 923
17
2017: 695