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 bag, urine collection, leg, for external use, sterile
Product CodeFAQ
Regulation Number 876.5250
Device Class 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 1 1
2016 13 13
2017 22 22
2018 3 3
2019 3 3
2020 1 1
2021 70 70
2022 48 48
2023 36 36
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 97 97
Component Missing 28 28
Biocompatibility 15 15
Deformation Due to Compressive Stress 13 13
Fluid/Blood Leak 8 8
No Flow 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Component Misassembled 6 6
Partial Blockage 5 5
Material Twisted/Bent 5 5
Obstruction of Flow 5 5
Kinked 4 4
Nonstandard Device 3 3
Device Operates Differently Than Expected 3 3
Material Rupture 3 3
Complete Blockage 3 3
Patient-Device Incompatibility 3 3
Physical Resistance/Sticking 3 3
Disconnection 3 3
Infusion or Flow Problem 2 2
Inadequate Instructions for Healthcare Professional 2 2
Improper Flow or Infusion 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Leak/Splash 2 2
Folded 1 1
Material Fragmentation 1 1
Inaccurate Flow Rate 1 1
Inflation Problem 1 1
Device Handling Problem 1 1
Microbial Contamination of Device 1 1
Collapse 1 1
Wrong Label 1 1
Occlusion Within Device 1 1
Sticking 1 1
Detachment of Device or Device Component 1 1
Filling Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Chemical or Other Material 1 1
Material Separation 1 1
Incorrect Measurement 1 1
Illegible Information 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate or Insufficient Training 1 1
Unexpected Therapeutic Results 1 1
Fungus in Device Environment 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Component 1 1
Difficult to Open or Close 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 145 145
Urinary Tract Infection 26 26
No Known Impact Or Consequence To Patient 25 25
No Consequences Or Impact To Patient 10 10
Sepsis 8 8
No Information 5 5
Urinary Retention 5 5
Discomfort 5 5
Unspecified Infection 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Patient Involvement 3 3
Insufficient Information 3 3
Patient Problem/Medical Problem 1 1
Skin Irritation 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1
Burn(s) 1 1
Rash 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II Jun-27-2011
-
-