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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

MDR Year MDR Reports MDR Events
2018 1 1
2019 4 4
2020 3 3
2023 1 1

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

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

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