GIVEN IMAGING LTD., YOQNEAM

Manufacturer adverse-event records for GIVEN IMAGING LTD., YOQNEAM 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 · 2017–2026 · thin-book · typical Death-code · balanced

Volume signature

GIVEN IMAGING LTD., YOQNEAM is a thinner MAUDE footprint

GIVEN IMAGING LTD., YOQNEAM accounts for 5,434 FDA MAUDE reports (#358 of 434, thin-book tercile). Death-coded event_type share is 0.15% (typical); Injury share 17.3% (balanced).

What the volume reading shows for GIVEN IMAGING LTD., YOQNEAM

The standout signal for GIVEN IMAGING LTD., YOQNEAM is filing volume: 5,434 adverse-event reports in FDA MAUDE (#358 of 434, thin-book). Death-coded event_type share sits at 0.15% (typical).

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 9 device types, led in this extract by Malfunction at 4,486 (82.6% of event_type total). Peak single-year volume reaches 962 reports across 10 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,434
Total Reports
8
Event-type Death
940
Injury Reports
9
Device Types

Event Types

Malfunction 4,486 (82.6%)
Injury 940 (17.3%)
Death 8 (0.1%)

Patient Outcomes

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

4,426 (80.1%)
Required Intervention 763 (13.8%)
Other 155 (2.8%)
R 73 (1.3%)
Hospitalization 57 (1.0%)
O 28 (0.5%)
H 14 (0.3%)
Death 8 (0.1%)
Life Threatening 3 (0.1%)
L 1 (0.0%)

Yearly Trend

17
2017: 842
18
2018: 962
19
2019: 645
20
2020: 757
21
2021: 512
22
2022: 268
23
2023: 259
24
2024: 247
25
2025: 583
26
2026: 359