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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
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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