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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mattress, flotation therapy, non-powered
Product CodeIKY
Regulation Number 880.5150
Device Class 1

MDR Year MDR Reports MDR Events
2017 27 27
2018 130 130
2019 45 102
2020 16 54
2021 13 49
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 138 269
Adverse Event Without Identified Device or Use Problem 31 31
Detachment of Device or Device Component 10 10
Insufficient Information 7 7
Patient Device Interaction Problem 6 6
Unintended Movement 6 6
Device Operates Differently Than Expected 5 5
Patient-Device Incompatibility 5 5
Component Falling 4 4
Use of Device Problem 3 3
No Apparent Adverse Event 3 3
Decrease in Pressure 3 3
Mechanical Problem 2 2
Device-Device Incompatibility 2 2
Material Deformation 2 2
Detachment Of Device Component 2 2
Difficult or Delayed Positioning 2 2
Material Discolored 1 1
Filling Problem 1 1
Fluid Leak 1 1
Inflation Problem 1 1
Kinked 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Break 1 1
Contamination 1 1
Use of Incorrect Control Settings 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Material Integrity Problem 1 1
Naturally Worn 1 1
Device Emits Odor 1 1
Contamination /Decontamination Problem 1 1
Delamination 1 1
Pressure Problem 1 1
Material Too Soft/Flexible 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 95 95
No Consequences Or Impact To Patient 58 116
Fall 26 37
Pressure Sores 26 26
Injury 10 10
No Clinical Signs, Symptoms or Conditions 9 45
Pain 6 6
No Patient Involvement 5 41
Tissue Damage 4 4
Death 3 3
Exposure to Body Fluids 2 2
Bruise/Contusion 2 2
Cardiogenic Shock 2 2
Skin Discoloration 2 2
Skin Tears 2 2
No Information 2 2
No Code Available 1 1
Insufficient Information 1 1
Numbness 1 1
Physical Entrapment 1 1
Discomfort 1 1
Bacterial Infection 1 1
Skin Irritation 1 1
Tinnitus 1 1
Respiratory Distress 1 1
Ulcer 1 1
Tingling 1 1
Stroke/CVA 1 1
Dyspnea 1 1
Fainting 1 1
Asphyxia 1 1
Headache 1 1
Muscle Weakness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EHOB, Inc. II Jun-24-2021
2 EHOB, Inc. II Mar-09-2020
3 Joerns Healthcare II May-30-2018
4 Stryker Medical Division of Stryker Corporation II Aug-06-2021
5 Stryker Medical Division of Stryker Corporation II Sep-25-2020
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