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Table, Cystometric, Non-Electric And Accessories

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FDA MAUDE adverse event data · 1994–2022

What the Data Shows About Table, Cystometric, Non-Electric And Accessories

The FDA MAUDE database aggregates 638 adverse-event reports for Table, Cystometric, Non-Electric And Accessories spanning the period from 1994 through 2022. Of these, 0 are classified as death reports, 5 as injury reports, and 624 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 4 distinct event types and 5 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 6 distinct product-problem codes appear in the reports, with Adverse Event Without Identified Device or Use Problem topping the list at 1 report. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 19 years of MAUDE data, with the peak single-year volume reaching 178 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 4 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

638
Total Reports
0
Death Reports
5
Injury Reports
624
Malfunctions

Event Types

Malfunction 624 (97.8%)
Other 6 (0.9%)
Injury 5 (0.8%)
3 (0.5%)

Patient Outcomes

619 (96.9%)
Other 16 (2.5%)
Required Intervention 2 (0.3%)
R 1 (0.2%)
Hospitalization 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1
Defective Device 1
No Display/Image 1
Output Problem 1
Physical Resistance/Sticking 1
Protective Measures Problem 1

Yearly Trend

94
1994: 1
95
1995: 1
96
1996: 3
97
1997: 2
98
1998: 1
01
2001: 1
02
2002: 3
06
2006: 2
07
2007: 2
08
2008: 138
09
2009: 178
10
2010: 106
11
2011: 172
12
2012: 21
13
2013: 2
14
2014: 1
16
2016: 1
20
2020: 2
22
2022: 1

Related Entities for Table, Cystometric, Non-Electric And Accessories

Event Locations

620 (97.2%)
HOSPITAL 14 (2.2%)
NO INFORMATION 3 (0.5%)
I 1 (0.2%)

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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 device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.