CONVATEC DOMINICAN REPUBLIC INC

FDA MAUDE device safety record · 2013–2026

What the Data Shows About CONVATEC DOMINICAN REPUBLIC INC

CONVATEC DOMINICAN REPUBLIC INC is associated with 44,325 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2013 through 2026. Of the total, 0 are coded as death reports and 341 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 16 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for CONVATEC DOMINICAN REPUBLIC INC should be reviewed at the device-family level rather than company-wide. Across those devices, 2 distinct event types appear in the record, led by Malfunction at 43,984 reports (99.2% of total). Patient-outcome categorizations are reported across 7 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 13 years of MAUDE data, with the peak single-year volume reaching 17,339 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.

44,325
Total Reports
0
Death Reports
341
Injury Reports
16
Device Types

Event Types

Malfunction 43,984 (99.2%)
Injury 341 (0.8%)

Patient Outcomes

44,238 (99.9%)
Death 31 (0.1%)
Required Intervention 8 (0.0%)
R 3 (0.0%)
Hospitalization 2 (0.0%)
H 1 (0.0%)
Other 1 (0.0%)

Yearly Trend

13
2013: 2
15
2015: 1
16
2016: 1
17
2017: 1
18
2018: 3,116
19
2019: 17,339
20
2020: 13,830
21
2021: 1,468
22
2022: 957
23
2023: 2,061
24
2024: 2,161
25
2025: 3,006
26
2026: 382

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.