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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
2018 1 1
2019 5 5
2020 3 3
2021 4 4
2022 60 60
2023 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 39 39
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
Inadequate or Insufficient Training 1 1
Fitting Problem 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Human-Device Interface Problem 1 1
Device Contaminated During Manufacture or Shipping 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 43 43
Insufficient Information 28 28
Pressure Sores 8 8
Tissue Breakdown 3 3
No Known Impact Or Consequence To Patient 1 1
Injury 1 1
Pain 1 1
Scar Tissue 1 1
Tissue Damage 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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