HOSPIRA COSTA RICA LTD.

FDA MAUDE device safety record · 2006–2018

What the Data Shows About HOSPIRA COSTA RICA LTD.

HOSPIRA COSTA RICA LTD. is associated with 15,653 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2006 through 2018. Of the total, 51 are coded as death reports and 243 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 HOSPIRA COSTA RICA LTD. should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 15,311 reports (97.8% 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 11 years of MAUDE data, with the peak single-year volume reaching 6,132 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.

15,653
Total Reports
51
Death Reports
243
Injury Reports
13
Device Types

Event Types

Malfunction 15,311 (97.8%)
Injury 243 (1.6%)
Death 51 (0.3%)
45 (0.3%)
Other 3 (0.0%)

Patient Outcomes

15,364 (97.6%)
Required Intervention 138 (0.9%)
R 81 (0.5%)
Life Threatening 69 (0.4%)
Death 52 (0.3%)
Hospitalization 22 (0.1%)
Other 8 (0.1%)
L 5 (0.0%)
S 2 (0.0%)

Yearly Trend

06
2006: 1
09
2009: 271
10
2010: 266
11
2011: 836
12
2012: 1,250
13
2013: 5,664
14
2014: 6,132
15
2015: 956
16
2016: 63
17
2017: 151
18
2018: 63

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.