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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, malecot
Regulation Description Suprapubic urological catheter and accessories.
Product CodeFEW
Regulation Number 876.5090
Device Class 2

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

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 3 3
Misassembled 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Subassembly 1 1
Migration 1 1
Connector 1 1
Shaft 1 1
Occlusion Within Device 1 1
Device Damaged Prior to Use 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Use of Device Problem 1 1
Material Protrusion/Extrusion 1 1
Insufficient Information 1 1
Incorrect Measurement 1 1
Off-Label Use 1 1

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

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