LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

Manufacturer adverse-event records for LIFESCAN EUROPE 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 · 2011–2019 · heavy-book · quiet Death-code · injury-light

Volume signature

LIFESCAN EUROPE sits in the heavy MAUDE book

LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL accounts for 223,382 FDA MAUDE reports (#13 of 443, heavy-book tercile). Death-coded event_type share is 0.00% (quiet); Injury share 4.2% (injury-light).

What the volume reading shows for LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

The standout signal for LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL is filing volume: 223,382 adverse-event reports in FDA MAUDE (#13 of 443, heavy-book). Death-coded event_type share sits at 0.00% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair LIFESCAN EUROPE with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 6 device types, led in this extract by Malfunction at 213,313 (95.5% of event_type total). Peak single-year volume reaches 64,697 reports across 9 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

223,382
Total Reports
4
Event-type Death
9,366
Injury Reports
6
Device Types

Event Types

Malfunction 213,313 (95.5%)
Injury 9,366 (4.2%)
697 (0.3%)
Death 4 (0.0%)
Other 2 (0.0%)

Patient Outcomes

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

214,369 (93.6%)
Life Threatening 8,159 (3.6%)
R 4,913 (2.1%)
Hospitalization 714 (0.3%)
L 685 (0.3%)
Required Intervention 134 (0.1%)
Death 5 (0.0%)
H 4 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

11
2011: 998
12
2012: 8,376
13
2013: 32,980
14
2014: 35,382
15
2015: 55,254
16
2016: 64,697
17
2017: 22,834
18
2018: 2,802
19
2019: 59