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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
2018 130 130
2019 45 102
2020 16 54
2021 13 49
2022 44 44
2023 23 23
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 128 259
Adverse Event Without Identified Device or Use Problem 40 40
Increase in Pressure 26 26
Use of Device Problem 12 12
Insufficient Information 10 10
Detachment of Device or Device Component 10 10
Patient Device Interaction Problem 7 7
Unintended Movement 5 5
No Apparent Adverse Event 5 5
Patient-Device Incompatibility 5 5
Device-Device Incompatibility 4 4
Component Falling 4 4
Inflation Problem 3 3
Pressure Problem 3 3
Material Split, Cut or Torn 3 3
Material Deformation 2 2
Contamination /Decontamination Problem 2 2
Mechanical Problem 2 2
Difficult or Delayed Positioning 2 2
Unclear Information 2 2
Material Discolored 1 1
Electrical /Electronic Property Problem 1 1
Fluid/Blood Leak 1 1
Contamination 1 1
Use of Incorrect Control/Treatment Settings 1 1
Degraded 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Break 1 1
Collapse 1 1
Fungus in Device Environment 1 1
Device Contamination with Body Fluid 1 1
Device Emits Odor 1 1
Delamination 1 1
Naturally Worn 1 1
Device Operates Differently Than Expected 1 1
Sharp Edges 1 1
Device Fell 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 83 83
No Consequences Or Impact To Patient 54 112
Fall 50 61
Pressure Sores 43 43
No Clinical Signs, Symptoms or Conditions 18 54
Injury 10 10
Pain 10 10
No Patient Involvement 5 41
Insufficient Information 5 5
Tissue Damage 3 3
Skin Tears 2 2
Physical Entrapment 2 2
Cardiogenic Shock 2 2
Ulcer 2 2
Exposure to Body Fluids 2 2
Bruise/Contusion 2 2
Death 2 2
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Asphyxia 1 1
Head Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Muscle Weakness 1 1
Nausea 1 1
Respiratory Distress 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Eye Burn 1 1
No Information 1 1
No Code Available 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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