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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
2017
27
27
2018
130
130
2019
45
102
2020
16
54
2021
13
49
2022
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Slipped
138
269
Adverse Event Without Identified Device or Use Problem
31
31
Detachment of Device or Device Component
10
10
Insufficient Information
7
7
Patient Device Interaction Problem
6
6
Unintended Movement
6
6
Device Operates Differently Than Expected
5
5
Patient-Device Incompatibility
5
5
Component Falling
4
4
Use of Device Problem
3
3
No Apparent Adverse Event
3
3
Decrease in Pressure
3
3
Mechanical Problem
2
2
Device-Device Incompatibility
2
2
Material Deformation
2
2
Detachment Of Device Component
2
2
Difficult or Delayed Positioning
2
2
Material Discolored
1
1
Filling Problem
1
1
Fluid Leak
1
1
Inflation Problem
1
1
Kinked
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Break
1
1
Contamination
1
1
Use of Incorrect Control Settings
1
1
Component Missing
1
1
Device Contamination with Body Fluid
1
1
Material Integrity Problem
1
1
Naturally Worn
1
1
Device Emits Odor
1
1
Contamination /Decontamination Problem
1
1
Delamination
1
1
Pressure Problem
1
1
Material Too Soft/Flexible
1
1
Material Split, Cut or Torn
1
1
Device Fell
1
1
Unclear Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
95
95
No Consequences Or Impact To Patient
58
116
Fall
26
37
Pressure Sores
26
26
Injury
10
10
No Clinical Signs, Symptoms or Conditions
9
45
Pain
6
6
No Patient Involvement
5
41
Tissue Damage
4
4
Death
3
3
Exposure to Body Fluids
2
2
Bruise/Contusion
2
2
Cardiogenic Shock
2
2
Skin Discoloration
2
2
Skin Tears
2
2
No Information
2
2
No Code Available
1
1
Insufficient Information
1
1
Numbness
1
1
Physical Entrapment
1
1
Discomfort
1
1
Bacterial Infection
1
1
Skin Irritation
1
1
Tinnitus
1
1
Respiratory Distress
1
1
Ulcer
1
1
Tingling
1
1
Stroke/CVA
1
1
Dyspnea
1
1
Fainting
1
1
Asphyxia
1
1
Headache
1
1
Muscle Weakness
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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