• 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 catheter, ureteral, general & plastic surgery
Regulation Description Urological catheter and accessories.
Product CodeGBL
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2015 8 8
2016 10 10
2017 25 25
2018 36 36
2019 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 25 25
Break 24 24
Catheter 10 10
Device Contamination with Chemical or Other Material 8 8
Stent 5 5
Material Fragmentation 5 5
Migration or Expulsion of Device 4 4
Insufficient Information 4 4
Contamination /Decontamination Problem 4 4
Detachment Of Device Component 4 4
Tip 3 3
Fracture 3 3
Difficult to Remove 2 2
Peeled/Delaminated 2 2
Unraveled Material 2 2
Device Damaged Prior to Use 2 2
Failure to Advance 2 2
Guidewire 2 2
Partial Blockage 2 2
Difficult to Advance 1 1
Device Contaminated During Manufacture or Shipping 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Entrapment of Device 1 1
Flaked 1 1
Kinked 1 1
Occlusion Within Device 1 1
Material Too Rigid or Stiff 1 1
Mechanical Problem 1 1
Obstruction of Flow 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Material Puncture/Hole 1 1
Bent 1 1
Crack 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 31 31
No Known Impact Or Consequence To Patient 23 23
Foreign Body In Patient 12 12
No Patient Involvement 11 11
No Code Available 8 8
Device Embedded In Tissue or Plaque 6 6
No Information 4 4
Unspecified Infection 3 3
Internal Organ Perforation 2 2
Foreign body, removal of 2 2
Perforation 2 2
Erosion 1 1
Nonresorbable materials, unretrieved in body 1 1
Respiratory Failure 1 1
Pain 1 1
Thromboembolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Feb-04-2020
2 Cook Inc. II Aug-22-2016
-
-