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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urinometer, electrical
Product CodeEXS
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
Failure to Calibrate 10 10
Incorrect Measurement 10 10
Circuit Failure 9 9
Computer Operating System Problem 8 8
Material Fragmentation 7 7
Intermittent Loss of Power 7 7
Use of Device Problem 7 7
Defective Component 6 6
Failure to Power Up 5 5
Inadequate or Insufficient Training 5 5
Unable to Obtain Readings 5 5
Defective Device 4 4
Improper Flow or Infusion 4 4
Device Handling Problem 4 4
Device Operates Differently Than Expected 4 4
Component Missing 4 4
Device Displays Incorrect Message 4 4
Failure to Sense 3 3
Inaccurate Flow Rate 3 3
Material Protrusion/Extrusion 3 3
Fitting Problem 3 3
Output Problem 2 2
Nonstandard Device 2 2
Incorrect Or Inadequate Test Results 2 2
Overheating of Device 2 2
Calibration Problem 2 2
Temperature Problem 2 2
Device Alarm System 2 2
Device Markings/Labelling Problem 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Improper Device Output 2 2
Data Problem 2 2
Material Twisted/Bent 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Dislodged or Dislocated 2 2
No Display/Image 1 1
Overfill 1 1
Appropriate Term/Code Not Available 1 1
Failure to Transmit Record 1 1
Electrical /Electronic Property Problem 1 1
False Reading From Device Non-Compliance 1 1
Program or Algorithm Execution Failure 1 1
Display Difficult to Read 1 1
False Alarm 1 1
Device Inoperable 1 1
Battery Problem 1 1
Failure to Read Input Signal 1 1
Loose or Intermittent Connection 1 1
Misassembly During Maintenance/Repair 1 1
Detachment of Device or Device Component 1 1
Inadequate User Interface 1 1
Labelling, Instructions for Use or Training Problem 1 1
No Device Output 1 1
Image Display Error/Artifact 1 1
Reset Problem 1 1
Patient Data Problem 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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