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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
Regulation Description Nonpowered flotation therapy mattress.
Product CodeIKY
Regulation Number 880.5150
Device Class 1

MDR Year MDR Reports MDR Events
2020 16 54
2021 13 49
2022 44 44
2023 23 23
2024 433 437
2025 29 54

Device Problems MDRs with this Device Problem Events in those MDRs
Increase in Pressure 26 26
Device Slipped 19 122
Adverse Event Without Identified Device or Use Problem 17 17
Use of Device Problem 9 9
Patient Device Interaction Problem 7 7
Insufficient Information 5 5
No Apparent Adverse Event 5 5
Device-Device Incompatibility 4 4
Patient-Device Incompatibility 4 4
Pressure Problem 2 2
Material Split, Cut or Torn 2 2
Difficult or Delayed Positioning 2 2
Inflation Problem 2 2
Collapse 1 1
Device Fell 1 1
Unclear Information 1 1
Contamination /Decontamination Problem 1 1
Degraded 1 1
Sharp Edges 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Deformation 1 1
Device Emits Odor 1 1
Detachment of Device or Device Component 1 1
Fungus in Device Environment 1 1
Material Too Soft/Flexible 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 406 471
Insufficient Information 68 68
Pressure Sores 36 36
Fall 30 65
Pain 8 8
No Patient Involvement 4 40
No Consequences Or Impact To Patient 4 6
Exposure to Body Fluids 2 2
Physical Entrapment 2 2
Dysphagia/ Odynophagia 2 2
Skin Tears 2 2
Death 1 1
Hypersensitivity/Allergic reaction 1 1
Hip Fracture 1 1
Failure of Implant 1 1
Nausea 1 1
Skin Irritation 1 1
Head Injury 1 1
Muscle Weakness 1 1
Eye Burn 1 1
Skin Discoloration 1 1
Injury 1 1
Pleural Effusion 1 1
Ulcer 1 1
Low Blood Pressure/ Hypotension 1 1
Internal Organ Perforation 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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