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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


Premarket Reviews
ManufacturerDecision
INVICTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 9 9
2016 11 11
2017 2 2
2018 1 1
2019 5 5
2020 3 3
2021 4 4
2022 60 60
2023 15 15
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 40 40
Unintended Deflation 29 29
Insufficient Information 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Appropriate Term/Code Not Available 3 3
Patient-Device Incompatibility 3 3
Nonstandard Device 2 2
Product Quality Problem 2 2
Fitting Problem 2 2
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Slipped 1 1
Inadequate or Insufficient Training 1 1
Off-Label Use 1 1
Human-Device Interface Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Positioning Failure 1 1
Material Discolored 1 1
Inflation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Signal Artifact/Noise 1 1
Burst Container or Vessel 1 1
Detachment Of Device Component 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
Insufficient Information 29 29
Pressure Sores 17 17
Skin Erosion 4 4
Injury 3 3
Tissue Breakdown 3 3
No Known Impact Or Consequence To Patient 3 3
No Information 1 1
No Patient Involvement 1 1
Tissue Damage 1 1
Ulceration 1 1
Weakness 1 1
No Consequences Or Impact To Patient 1 1
Ulcer 1 1
Abscess 1 1
Fall 1 1
Pain 1 1
Scar Tissue 1 1
Skin Discoloration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jan-06-2016
2 EHOB, Inc. II Jul-20-2020
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