Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device urinometer, mechanical
Product CodeEXR
Regulation Number 876.1800
Device Class 2

MDR Year MDR Reports MDR Events
2014 31 31
2015 61 61
2016 3 3
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 23 23
Occlusion Within Device 18 18
Detachment Of Device Component 7 7
No Flow 7 7
Leak/Splash 6 6
Device Operates Differently Than Expected 5 5
Defective Component 5 5
Infusion or Flow Problem 5 5
Decoupling 3 3
Unable to Obtain Readings 3 3
Restricted Flow rate 3 3
Partial Blockage 3 3
Break 3 3
Mechanical Problem 2 2
Delivered as Unsterile Product 2 2
Connection Problem 2 2
Positioning Problem 2 2
Free or Unrestricted Flow 1 1
Component Missing 1 1
Migration or Expulsion of Device 1 1
Positioning Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Complete Blockage 1 1
Loss of or Failure to Bond 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 83 83
Insufficient Information 7 7
Not Applicable 6 6
No Clinical Signs, Symptoms or Conditions 4 4
Urinary Retention 3 3
No Patient Involvement 2 2
Alteration In Body Temperature 1 1
Foreign Body In Patient 1 1
Micturition Urgency 1 1
Pain 1 1

-
-