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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
2019 5 5
2020 3 4
2021 4 4
2022 60 60
2023 15 15
2024 10 10
2025 35 35
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 40 40
Unintended Deflation 29 29
Inadequate or Insufficient Training 25 25
Adverse Event Without Identified Device or Use Problem 7 7
Inadequate Instructions for Healthcare Professional 3 3
Appropriate Term/Code Not Available 3 3
Material Split, Cut or Torn 2 2
Patient-Device Incompatibility 2 3
Patient Device Interaction Problem 2 2
Product Quality Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Burst Container or Vessel 1 1
Mechanical Problem 1 1
Collapse 1 1
Insufficient Information 1 1
Defective Device 1 1
Positioning Failure 1 1
Inflation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Detachment of Device or Device Component 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 59 59
Insufficient Information 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Pressure Sores 9 9
Skin Inflammation/ Irritation 3 3
Tissue Breakdown 3 3
Blister 1 1
No Known Impact Or Consequence To Patient 1 1
Injury 1 1
Weakness 1 2
Erythema 1 1
Pain 1 2
Scar Tissue 1 1
Abscess 1 1
Unspecified Tissue Injury 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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