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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 10 10

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
Burst Container or Vessel 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Positioning Failure 1 1
Labelling, Instructions for Use or Training Problem 1 1
Human-Device Interface Problem 1 1
Inadequate or Insufficient Training 1 1
Nonstandard Device 1 1
Device Contaminated During Manufacture or Shipping 1 1
Inflation Problem 1 1
Improper or Incorrect Procedure or Method 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
Blister 1 1
No Known Impact Or Consequence To Patient 1 1
Injury 1 1
Weakness 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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