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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, suprapubic (and accessories)
Product CodeKOB
Regulation Number 876.5090
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2

MDR Year MDR Reports MDR Events
2017 12 12
2018 18 18
2019 4 4
2020 1 1
2021 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Deflation Problem 5 5
Leak/Splash 4 4
Device Dislodged or Dislocated 4 4
Detachment Of Device Component 3 3
Material Separation 3 3
Device Operates Differently Than Expected 3 3
Detachment of Device or Device Component 2 2
Unraveled Material 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Torn Material 1 1
Insufficient Information 1 1
Physical Resistance/Sticking 1 1
Device Contamination with Chemical or Other Material 1 1
Material Twisted/Bent 1 1
No Flow 1 1
Component Missing 1 1
Contamination /Decontamination Problem 1 1
Device Slipped 1 1
Material Fragmentation 1 1
Inflation Problem 1 1
Component Falling 1 1
Burst Container or Vessel 1 1
Migration or Expulsion of Device 1 1
Occlusion Within Device 1 1
Unsealed Device Packaging 1 1
Difficult To Position 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 14 14
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 3 3
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
Peritonitis 1 1
Foreign Body In Patient 1 1
Internal Organ Perforation 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Feb-04-2020
2 Cook Inc. II May-17-2019
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