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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2018 7 7
2019 8 8
2020 4 4
2021 12 12
2022 6 6
2023 12 12
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 20 20
Use of Device Problem 10 10
Improper or Incorrect Procedure or Method 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Material Split, Cut or Torn 2 2
Deflation Problem 2 2
Device Difficult to Maintain 2 2
Device Slipped 1 1
Fitting Problem 1 1
Material Puncture/Hole 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Air Leak 1 1
Material Deformation 1 1
Explosion 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 41 41
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 3 3
Unspecified Infection 2 2
Hip Fracture 1 1
No Information 1 1
Bone Fracture(s) 1 1
Cellulitis 1 1
Injury 1 1
Laceration(s) 1 1
Tissue Damage 1 1
Tissue Breakdown 1 1

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