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TPLC
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show TPLC since
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Device
mattress, flotation therapy, non-powered
Product Code
IKY
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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