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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, malecot
Product CodeFEW
Regulation Number 876.5090
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 3 3
2017 2 2
2018 1 1
2019 4 4
2020 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Material Puncture/Hole 3 3
Misassembled 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Occlusion Within Device 1 1
Unraveled Material 1 1
Use of Device Problem 1 1
Incorrect Measurement 1 1
Migration 1 1
Difficult to Remove 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Damaged Prior to Use 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 4 4
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 3 3
Ulceration 3 3
Device Embedded In Tissue or Plaque 2 2
Ulcer 2 2
No Clinical Signs, Symptoms or Conditions 2 2
No Patient Involvement 2 2
Foreign Body In Patient 2 2
Death 1 1
Fistula 1 1
Renal Failure 1 1
Liver Damage/Dysfunction 1 1
Patient Problem/Medical Problem 1 1

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