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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
2019 45 102
2020 16 54
2021 13 49
2022 44 44
2023 23 23
2024 5 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37 37
Device Slipped 32 167
Increase in Pressure 26 26
Use of Device Problem 9 9
Insufficient Information 7 7
Patient Device Interaction Problem 7 7
No Apparent Adverse Event 5 5
Device-Device Incompatibility 4 4
Patient-Device Incompatibility 4 4
Pressure Problem 3 3
Inflation Problem 3 3
Material Split, Cut or Torn 3 3
Unclear Information 2 2
Difficult or Delayed Positioning 2 2
Electrical /Electronic Property Problem 1 1
Collapse 1 1
Use of Incorrect Control/Treatment Settings 1 1
Degraded 1 1
Fungus in Device Environment 1 1
Unintended Movement 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Material Too Soft/Flexible 1 1
Sharp Edges 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 42 42
Fall 39 50
No Consequences Or Impact To Patient 30 88
No Clinical Signs, Symptoms or Conditions 19 59
Pain 7 7
Injury 5 5
Insufficient Information 5 5
No Patient Involvement 4 40
Tissue Damage 3 3
Skin Tears 2 2
Cardiogenic Shock 2 2
Ulcer 2 2
Physical Entrapment 2 2
Death 2 2
Dysphagia/ Odynophagia 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Asphyxia 1 1
Head Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Muscle Weakness 1 1
Nausea 1 1
Eye Burn 1 1
No Known Impact Or Consequence To Patient 1 1

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