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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 - KIT 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 1 1
2021 2 2
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unraveled Material 2 2
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Deflation Problem 1 1
Fluid/Blood Leak 1 1
Unsealed Device Packaging 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 3 3
Peritonitis 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Failure of Implant 1 1
Internal Organ Perforation 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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