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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cushion, flotation
Regulation Description Flotation cushion.
Product CodeKIC
Regulation Number 890.3175
Device Class 1

MDR Year MDR Reports MDR Events
2021 12 12
2022 6 6
2023 12 12
2024 14 14
2025 8 8
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 19 19
Use of Device Problem 7 7
Material Split, Cut or Torn 2 2
Material Integrity Problem 2 2
Device Difficult to Maintain 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Slipped 1 1
Mechanical Problem 1 1
Material Puncture/Hole 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Deflation Problem 1 1
Patient Device Interaction Problem 1 1
Gas/Air Leak 1 1
Material Perforation 1 1
Material Deformation 1 1
Explosion 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 37 37
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 6 6
Skin Erosion 2 2
Cellulitis 1 1
Laceration(s) 1 1
Tissue Breakdown 1 1

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