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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
2014 26 26
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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 40 40
Unintended Deflation 29 29
Insufficient Information 17 17
Adverse Event Without Identified Device or Use Problem 12 12
Device Contamination with Chemical or Other Material 9 9
Material Integrity Problem 5 5
Patient-Device Incompatibility 3 3
Appropriate Term/Code Not Available 3 3
Fitting Problem 2 2
Contamination 2 2
Material Discolored 2 2
Product Quality Problem 2 2
Nonstandard Device 2 2
Improper or Incorrect Procedure or Method 2 2
Device Slipped 1 1
Leak/Splash 1 1
Signal Artifact/Noise 1 1
Device Contaminated During Manufacture or Shipping 1 1
Off-Label Use 1 1
Burst Container or Vessel 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Device 1 1
Inadequate Instructions for Healthcare Professional 1 1
Patient Device Interaction Problem 1 1
Moisture Damage 1 1
Positioning Failure 1 1
Labelling, Instructions for Use or Training Problem 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Inflation Problem 1 1
Packaging Problem 1 1
Human-Device Interface Problem 1 1
Inadequate or Insufficient Training 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 18 18
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 8 8
Skin Erosion 4 4
Injury 3 3
No Patient Involvement 3 3
Fall 3 3
Tissue Damage 3 3
Tissue Breakdown 3 3
Death 2 2
Obstruction/Occlusion 2 2
Confusion/ Disorientation 2 2
Intracranial Hemorrhage 2 2
Laceration(s) 2 2
Ulcer 2 2
Fungal Infection 1 1
Necrosis 1 1
No Information 1 1
Blister 1 1
Skin Discoloration 1 1
Weakness 1 1
Erythema 1 1
Pain 1 1
Scar Tissue 1 1
Abscess 1 1
Ulceration 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jan-06-2016
2 Childrens Medical Ventures I Aug-20-2014
3 EHOB, Inc. II Jul-20-2020
4 Philips Medical Systems, Inc. I Dec-16-2014
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