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TPLC
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show TPLC since
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2024
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Device
bed, therapeutic, ac-powered, adjustable home-use
Product Code
LLI
Regulation Number
880.5100
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
13
13
2016
4
4
2017
44
44
2018
17
17
2019
95
95
2020
16
16
2021
3
3
2022
11
11
2023
20
20
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
77
77
Adverse Event Without Identified Device or Use Problem
28
28
Temperature Problem
15
15
Unintended Movement
12
12
Appropriate Term/Code Not Available
11
11
Break
9
9
Detachment Of Device Component
9
9
Insufficient Information
7
7
Fire
5
5
Misassembled
5
5
Device Slipped
5
5
Unstable
5
5
Use of Device Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Electrical /Electronic Property Problem
4
4
Material Integrity Problem
4
4
Material Protrusion/Extrusion
3
3
No Apparent Adverse Event
3
3
Thermal Decomposition of Device
3
3
Device Operates Differently Than Expected
3
3
Patient-Device Incompatibility
2
2
Component Missing
2
2
Device Issue
2
2
Smoking
2
2
Material Puncture/Hole
2
2
Bent
2
2
Unintended System Motion
2
2
Kinked
2
2
Loose or Intermittent Connection
2
2
Device Maintenance Issue
2
2
Mechanical Problem
2
2
Separation Problem
2
2
Installation-Related Problem
2
2
Missing Value Reason
2
2
Device Handling Problem
1
1
Activation Failure
1
1
Patient Device Interaction Problem
1
1
Component Misassembled
1
1
Explosion
1
1
Sharp Edges
1
1
Device Fell
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Positioning Problem
1
1
Material Torqued
1
1
Mechanical Jam
1
1
Misassembled During Installation
1
1
Melted
1
1
No Device Output
1
1
Overheating of Device
1
1
Misconnection
1
1
Device Emits Odor
1
1
Material Fragmentation
1
1
Collapse
1
1
Component Falling
1
1
Crack
1
1
Product Quality Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Inoperable
1
1
Material Perforation
1
1
Split
1
1
Sparking
1
1
Component or Accessory Incompatibility
1
1
Human-Device Interface Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
79
79
Fall
72
72
No Known Impact Or Consequence To Patient
29
29
No Clinical Signs, Symptoms or Conditions
17
17
Laceration(s)
16
16
Hematoma
9
9
Injury
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Bone Fracture(s)
5
5
Bruise/Contusion
3
3
Burn(s)
3
3
Electric Shock
3
3
Physical Entrapment
3
3
Contusion
2
2
Abrasion
2
2
Eye Injury
2
2
Pain
2
2
Swelling
2
2
Thrombosis
1
1
Concussion
1
1
Pressure Sores
1
1
Shock
1
1
Sprain
1
1
Head Injury
1
1
Death
1
1
Fracture, Arm
1
1
No Information
1
1
Missing Value Reason
1
1
Cough
1
1
Unspecified Respiratory Problem
1
1
Multiple Fractures
1
1
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Craftmatic Industries, Inc.
II
Aug-04-2022
2
GF Health Products, Inc./d.b.a.Basic American Metal Products
II
May-11-2012
3
Invacare Corporation
II
Mar-04-2024
4
Invacare Corporation
II
Feb-09-2017
5
Invacare Corporation
II
Nov-14-2011
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