MDT PUERTO RICO OPERATIONS CO., JUNCOS

FDA MAUDE device safety record · 2007–2012

What the Data Shows About MDT PUERTO RICO OPERATIONS CO., JUNCOS

MDT PUERTO RICO OPERATIONS CO., JUNCOS is associated with 10,885 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2007 through 2012. Of the total, 105 are coded as death reports and 5,553 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 10 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for MDT PUERTO RICO OPERATIONS CO., JUNCOS 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 Injury at 5,553 reports (51.0% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 5 years of MAUDE data, with the peak single-year volume reaching 6,000 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.

10,885
Total Reports
105
Death Reports
5,553
Injury Reports
10
Device Types

Event Types

Injury 5,553 (51.0%)
Malfunction 5,210 (47.9%)
Death 105 (1.0%)
Other 9 (0.1%)
8 (0.1%)

Patient Outcomes

5,229 (45.5%)
Required Intervention 4,347 (37.8%)
Hospitalization 696 (6.1%)
Other 460 (4.0%)
R 446 (3.9%)
Death 103 (0.9%)
O 63 (0.5%)
L 51 (0.4%)
H 34 (0.3%)
Life Threatening 29 (0.3%)
S 18 (0.2%)
Disability 16 (0.1%)
Congenital Anomaly 5 (0.0%)
D 4 (0.0%)

Yearly Trend

07
2007: 40
09
2009: 310
10
2010: 6,000
11
2011: 4,532
12
2012: 3

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.