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TPLC
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show TPLC since
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Device
urinometer, electrical
Product Code
EXS
Regulation Number
876.1800
Device Class
2
MDR Year
MDR Reports
MDR Events
2017
29
29
2018
16
16
2019
18
18
2020
13
13
2021
33
33
2022
226
226
2023
97
97
Device Problems
MDRs with this Device Problem
Events in those MDRs
Volume Accuracy Problem
96
96
Device Sensing Problem
86
86
Display or Visual Feedback Problem
50
50
Component Misassembled
33
33
Computer Software Problem
32
32
Operating System Becomes Nonfunctional
24
24
Incorrect, Inadequate or Imprecise Result or Readings
21
21
Restricted Flow rate
20
20
Erratic or Intermittent Display
13
13
Break
12
12
Incorrect Measurement
10
10
Failure to Calibrate
10
10
Circuit Failure
9
9
Computer Operating System Problem
8
8
Intermittent Loss of Power
7
7
Material Fragmentation
7
7
Use of Device Problem
7
7
Defective Component
6
6
Failure to Power Up
5
5
Unable to Obtain Readings
5
5
Inadequate or Insufficient Training
5
5
Component Missing
4
4
Device Operates Differently Than Expected
4
4
Device Handling Problem
4
4
Defective Device
4
4
Device Displays Incorrect Message
4
4
Improper Flow or Infusion
4
4
Material Protrusion/Extrusion
3
3
Fitting Problem
3
3
Failure to Sense
3
3
Inaccurate Flow Rate
3
3
Device Alarm System
2
2
Application Interface Becomes Non-Functional Or Program Exits Abnormally
2
2
Nonstandard Device
2
2
Overheating of Device
2
2
Incorrect Or Inadequate Test Results
2
2
Material Twisted/Bent
2
2
Output Problem
2
2
Temperature Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Device Dislodged or Dislocated
2
2
Improper Device Output
2
2
Calibration Problem
2
2
Device Markings/Labelling Problem
2
2
Data Problem
2
2
Patient Data Problem
1
1
Program or Algorithm Execution Failure
1
1
Misassembly During Maintenance/Repair
1
1
Battery Problem
1
1
Detachment of Device or Device Component
1
1
Appropriate Term/Code Not Available
1
1
Reset Problem
1
1
Inadequate User Interface
1
1
Overfill
1
1
No Device Output
1
1
Failure to Transmit Record
1
1
Failure to Read Input Signal
1
1
Device Inoperable
1
1
Display Difficult to Read
1
1
No Display/Image
1
1
False Alarm
1
1
Electrical /Electronic Property Problem
1
1
False Reading From Device Non-Compliance
1
1
Image Display Error/Artifact
1
1
Labelling, Instructions for Use or Training Problem
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
263
263
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
102
102
No Known Impact Or Consequence To Patient
55
55
No Consequences Or Impact To Patient
21
21
No Patient Involvement
21
21
No Information
12
12
Insufficient Information
4
4
Cramp(s) /Muscle Spasm(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
C.R. Bard Inc
II
Dec-14-2023
2
C.R. Bard Inc
II
Jun-27-2022
3
C.R. Bard, Inc.
II
Jun-15-2018
4
C.R. Bard, Inc.
II
Feb-09-2018
5
C.R. Bard, Inc.
II
Jan-29-2018
6
C.R. Bard, Inc., Urological Division
III
Dec-21-2010
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