DISETRONIC MEDICAL SYSTEMS

Manufacturer adverse-event records for DISETRONIC MEDICAL SYSTEMS come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1994–2010 · thin-book · typical Death-code · injury-heavy

Volume signature

DISETRONIC MEDICAL SYSTEMS is a thinner MAUDE footprint

DISETRONIC MEDICAL SYSTEMS accounts for 5,955 FDA MAUDE reports (#328 of 443, thin-book tercile). Death-coded event_type share is 0.30% (typical); Injury share 55.4% (injury-heavy).

What the volume reading shows for DISETRONIC MEDICAL SYSTEMS

The standout signal for DISETRONIC MEDICAL SYSTEMS is filing volume: 5,955 adverse-event reports in FDA MAUDE (#328 of 443, thin-book). Death-coded event_type share sits at 0.30% (typical).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 4 device types, led in this extract by Injury at 3,302 (55.4% of event_type total). Peak single-year volume reaches 3,081 reports across 16 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,955
Total Reports
18
Event-type Death
3,302
Injury Reports
4
Device Types

Event Types

Injury 3,302 (55.4%)
Malfunction 2,622 (44.0%)
Death 18 (0.3%)
13 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

2,677 (36.8%)
Required Intervention 2,109 (29.0%)
R 1,070 (14.7%)
Other 659 (9.1%)
Hospitalization 481 (6.6%)
O 228 (3.1%)
Death 21 (0.3%)
L 16 (0.2%)
Life Threatening 8 (0.1%)
H 5 (0.1%)
S 1 (0.0%)

Yearly Trend

94
1994: 1
95
1995: 3
96
1996: 4
97
1997: 29
98
1998: 17
99
1999: 2
00
2000: 3
01
2001: 6
02
2002: 26
03
2003: 37
04
2004: 28
05
2005: 89
06
2006: 17
08
2008: 1,802
09
2009: 3,081
10
2010: 810