Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
bath, sitz, powered
Product Code
ILM
Regulation Number
890.5100
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
61
61
2015
14
14
2016
20
20
2017
6
6
2018
2
2
2019
6
6
2020
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Maintenance Does Not Comply To Manufacturers Recommendations
28
28
Device Tipped Over
19
19
Component Falling
15
15
Installation-Related Problem
13
13
Adverse Event Without Identified Device or Use Problem
12
12
Use of Device Problem
12
12
Detachment Of Device Component
11
11
Device Operational Issue
10
10
Leak/Splash
10
10
Unintended Movement
8
8
Detachment of Device or Device Component
6
6
Device Maintenance Issue
6
6
Device Dislodged or Dislocated
5
5
No Apparent Adverse Event
5
5
Temperature Problem
5
5
Human Factors Issue
5
5
Chemical Spillage
5
5
Unstable
4
4
Shelf Life Exceeded
4
4
Break
3
3
Biofilm coating in Device
3
3
Environmental Compatibility Problem
3
3
Microbial Contamination of Device
3
3
Smoking
2
2
Positioning Problem
2
2
Overheating of Device
2
2
Calibration Problem
2
2
Unintended System Motion
1
1
Device Operates Differently Than Expected
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Use of Incorrect Control/Treatment Settings
1
1
Battery Problem
1
1
Failure To Adhere Or Bond
1
1
Overfill
1
1
Disconnection
1
1
Fluid/Blood Leak
1
1
Hole In Material
1
1
Failure to Disinfect
1
1
Mechanical Jam
1
1
Device Inoperable
1
1
Component Incompatible
1
1
Device Fell
1
1
Filling Problem
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
41
41
Fall
19
19
Injury
15
15
Pain
12
12
No Known Impact Or Consequence To Patient
9
9
Bruise/Contusion
8
8
No Patient Involvement
6
6
Urinary Tract Infection
5
5
Skin Tears
4
4
Superficial (First Degree) Burn
3
3
Bone Fracture(s)
3
3
Head Injury
3
3
Abrasion
3
3
Chemical Exposure
3
3
Irritation
3
3
Laceration(s)
3
3
Partial thickness (Second Degree) Burn
3
3
Tingling
2
2
Muscle Weakness
2
2
Burn(s)
2
2
Concussion
2
2
Eye Injury
2
2
Tissue Damage
2
2
Caustic/Chemical Burns
2
2
Headache
2
2
Sore Throat
2
2
Death
1
1
Sweating
1
1
Skin Irritation
1
1
Palpitations
1
1
Alteration In Body Temperature
1
1
Loss of consciousness
1
1
Ambulation Difficulties
1
1
-
-