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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
Product CodeFMP
Regulation Number 880.6450
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 3 3
2021 4 4
2022 60 60
2023 15 15
2024 9 9

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 6 6
Appropriate Term/Code Not Available 3 3
Product Quality Problem 2 2
Patient-Device Incompatibility 2 2
Human-Device Interface Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Inadequate or Insufficient Training 1 1
Defective Device 1 1
Positioning Failure 1 1
Inflation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Nonstandard Device 1 1
Burst Container or Vessel 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51 51
Insufficient Information 29 29
Pressure Sores 8 8
Tissue Breakdown 3 3
No Known Impact Or Consequence To Patient 1 1
Injury 1 1
Abscess 1 1
Pain 1 1
Scar Tissue 1 1
Weakness 1 1
Ulcer 1 1

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