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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device protector, skin pressure
Regulation Description Skin pressure protectors.
Product CodeFMP
Regulation Number 880.6450
Device Class 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 60 60
2023 15 15
2024 10 10
2025 35 35
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 40 40
Unintended Deflation 29 29
Inadequate or Insufficient Training 24 24
Adverse Event Without Identified Device or Use Problem 4 4
Inadequate Instructions for Healthcare Professional 3 3
Appropriate Term/Code Not Available 3 3
Patient Device Interaction Problem 2 2
Material Split, Cut or Torn 2 2
Product Quality Problem 2 2
Mechanical Problem 1 1
Nonstandard Device 1 1
Insufficient Information 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Human-Device Interface Problem 1 1
Inflation Problem 1 1
Burst Container or Vessel 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
Insufficient Information 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Pressure Sores 4 4
Skin Inflammation/ Irritation 3 3
Tissue Breakdown 3 3
Blister 2 2
Skin Erosion 1 1
Erythema 1 1
Scar Tissue 1 1
Abscess 1 1
Unspecified Tissue Injury 1 1
Ulcer 1 1
Skin Tears 1 1

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