INVACARE FLORIDA OPERATIONS

FDA MAUDE device safety record · 2009–2016

What the Data Shows About INVACARE FLORIDA OPERATIONS

INVACARE FLORIDA OPERATIONS is associated with 48,885 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2009 through 2016. Of the total, 41 are coded as death reports and 63 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 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for INVACARE FLORIDA OPERATIONS 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 48,744 reports (99.7% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 8 years of MAUDE data, with the peak single-year volume reaching 23,380 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.

48,885
Total Reports
41
Death Reports
63
Injury Reports
20
Device Types

Event Types

Malfunction 48,744 (99.7%)
Injury 63 (0.1%)
Death 41 (0.1%)
33 (0.1%)
Other 4 (0.0%)

Patient Outcomes

Other 43,938 (89.8%)
4,830 (9.9%)
Hospitalization 51 (0.1%)
Death 44 (0.1%)
R 16 (0.0%)
O 13 (0.0%)
Congenital Anomaly 9 (0.0%)
Required Intervention 9 (0.0%)
L 7 (0.0%)
Life Threatening 3 (0.0%)
H 2 (0.0%)
Disability 1 (0.0%)

Yearly Trend

09
2009: 8
10
2010: 1
11
2011: 86
12
2012: 488
13
2013: 2,699
14
2014: 23,380
15
2015: 18,606
16
2016: 3,617

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.