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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
2020 3 3
2021 4 4
2022 60 60
2023 15 15
2024 10 10
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 40 40
Unintended Deflation 29 29
Adverse Event Without Identified Device or Use Problem 5 5
Appropriate Term/Code Not Available 3 3
Patient-Device Incompatibility 2 2
Product Quality Problem 2 2
Burst Container or Vessel 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Inflation Problem 1 1
Nonstandard Device 1 1
Human-Device Interface Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 54 54
Insufficient Information 29 29
Pressure Sores 4 4
Tissue Breakdown 3 3
Blister 1 1
Weakness 1 1
Injury 1 1
Erythema 1 1
Pain 1 1
Scar Tissue 1 1
Abscess 1 1
Ulcer 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EHOB, Inc. II Jul-20-2020
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