HAMILTON BONADUZ AG

FDA MAUDE device safety record · 1996–2014

What the Data Shows About HAMILTON BONADUZ AG

HAMILTON BONADUZ AG is associated with 4,327 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1996 through 2014. Of the total, 0 are coded as death reports and 0 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 9 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for HAMILTON BONADUZ AG should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 3,020 reports (69.8% of total). Patient-outcome categorizations are reported across 2 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 575 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.

4,327
Total Reports
0
Death Reports
0
Injury Reports
9
Device Types

Event Types

Malfunction 3,020 (69.8%)
Other 1,298 (30.0%)
9 (0.2%)

Patient Outcomes

2,183 (50.4%)
Other 2,145 (49.6%)

Yearly Trend

96
1996: 31
97
1997: 110
98
1998: 211
99
1999: 189
00
2000: 205
01
2001: 147
02
2002: 38
03
2003: 21
04
2004: 270
05
2005: 450
06
2006: 452
07
2007: 575
08
2008: 440
09
2009: 278
10
2010: 176
11
2011: 195
12
2012: 226
13
2013: 310
14
2014: 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.