Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 38 63

Device Problems MDRs with this Device Problem Events in those MDRs
Increase in Pressure 26 26
Adverse Event Without Identified Device or Use Problem 21 21
Device Slipped 19 122
Use of Device Problem 9 9
Insufficient Information 8 8
Patient Device Interaction Problem 7 7
No Apparent Adverse Event 5 5
Device-Device Incompatibility 4 4
Patient-Device Incompatibility 4 4
Material Split, Cut or Torn 3 3
Pressure Problem 2 2
Fire 2 2
Difficult or Delayed Positioning 2 2
Inflation Problem 2 2
Device Contamination with Body Fluid 1 1
Crack 1 1
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 69 69
Pressure Sores 38 38
Fall 31 66
Pain 8 8
No Patient Involvement 4 40
No Consequences Or Impact To Patient 4 6
Exposure to Body Fluids 3 3
Burn(s) 2 2
Physical Entrapment 2 2
Dysphagia/ Odynophagia 2 2
Skin Tears 2 2
Death 1 1
Hypersensitivity/Allergic reaction 1 1
Pneumothorax 1 1
Hip Fracture 1 1
Failure of Implant 1 1
Nausea 1 1
Skin Irritation 1 1
Fungal Infection 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
Discomfort 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
-
-