HAMILTON MEDICAL AG

FDA MAUDE device safety record · 2002–2026

What the Data Shows About HAMILTON MEDICAL AG

HAMILTON MEDICAL AG is associated with 16,208 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2002 through 2026. Of the total, 58 are coded as death reports and 184 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 HAMILTON MEDICAL AG should be reviewed at the device-family level rather than company-wide. Across those devices, 6 distinct event types appear in the record, led by Malfunction at 15,957 reports (98.5% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 19 years of MAUDE data, with the peak single-year volume reaching 10,095 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.

16,208
Total Reports
58
Death Reports
184
Injury Reports
10
Device Types

Event Types

Malfunction 15,957 (98.5%)
Injury 184 (1.1%)
Death 58 (0.4%)
Other 5 (0.0%)
2 (0.0%)
No answer provided 2 (0.0%)

Patient Outcomes

15,714 (96.6%)
Required Intervention 269 (1.7%)
Other 79 (0.5%)
Death 68 (0.4%)
Life Threatening 36 (0.2%)
Disability 23 (0.1%)
O 20 (0.1%)
R 17 (0.1%)
L 14 (0.1%)
Hospitalization 9 (0.1%)
D 5 (0.0%)
H 5 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

02
2002: 3
04
2004: 5
06
2006: 3
07
2007: 1
08
2008: 1
11
2011: 3
13
2013: 1
14
2014: 2
16
2016: 2
17
2017: 4
18
2018: 3
19
2019: 20
20
2020: 33
21
2021: 29
22
2022: 93
23
2023: 10,095
24
2024: 4,842
25
2025: 976
26
2026: 92

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.