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TPLC
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Device
walker, mechanical
Regulation Description
Mechanical walker.
Product Code
ITJ
Regulation Number
890.3825
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
117
117
2021
81
81
2022
114
114
2023
140
140
2024
84
84
2025
36
36
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
108
108
Mechanical Problem
53
53
Appropriate Term/Code Not Available
50
50
Fracture
49
49
Adverse Event Without Identified Device or Use Problem
46
46
Insufficient Information
34
34
Material Integrity Problem
24
24
Use of Device Problem
22
22
Unintended Movement
20
20
Material Twisted/Bent
19
19
Detachment of Device or Device Component
18
18
Material Fragmentation
15
15
Collapse
13
13
Sharp Edges
13
13
Solder Joint Fracture
11
11
Improper or Incorrect Procedure or Method
7
7
Defective Component
7
7
Loose or Intermittent Connection
5
5
Crack
5
5
Device Dislodged or Dislocated
4
4
Component Missing
4
4
Off-Label Use
4
4
Failure to Align
4
4
Patient Device Interaction Problem
4
4
Material Separation
3
3
Device Slipped
3
3
Device Damaged Prior to Use
3
3
Unintended System Motion
3
3
Structural Problem
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Device Fell
3
3
Human-Device Interface Problem
2
2
Device Unsafe to Use in Environment
2
2
Defective Device
2
2
No Apparent Adverse Event
2
2
Misassembly by Users
2
2
Protective Measures Problem
2
2
Naturally Worn
2
2
Mechanical Jam
2
2
Material Protrusion/Extrusion
2
2
Material Deformation
2
2
Material Frayed
2
2
Product Quality Problem
2
2
Unintended Collision
2
2
Unstable
2
2
Device Handling Problem
1
1
Separation Problem
1
1
Misassembled During Installation
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Failure to Advance
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
218
218
Laceration(s)
101
101
Bone Fracture(s)
93
93
Bruise/Contusion
45
45
No Clinical Signs, Symptoms or Conditions
44
44
Head Injury
41
41
Pain
32
32
Insufficient Information
26
26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
16
Limb Fracture
16
16
Hip Fracture
15
15
Concussion
15
15
Damage to Ligament(s)
12
12
Easy Bruising
10
10
Joint Dislocation
8
8
Vertebral Fracture
8
8
Abrasion
7
7
Swelling/ Edema
6
6
Hemorrhage/Bleeding
6
6
Muscle/Tendon Damage
5
5
Neck Pain
5
5
Skin Tears
5
5
No Consequences Or Impact To Patient
4
4
No Known Impact Or Consequence To Patient
4
4
Injury
4
4
Brain Injury
4
4
Hematoma
3
3
Tooth Fracture
3
3
Unspecified Tissue Injury
3
3
Headache
2
2
Multiple Fractures
2
2
Eye Injury
1
1
Erythema
1
1
No Patient Involvement
1
1
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Stroke/CVA
1
1
Balance Problems
1
1
Convulsion/Seizure
1
1
Thrombosis/Thrombus
1
1
Bacterial Infection
1
1
Cognitive Changes
1
1
Memory Loss/Impairment
1
1
Myocardial Infarction
1
1
Ambulation Difficulties
1
1
Perforation
1
1
Scar Tissue
1
1
Skull Fracture
1
1
Spinal Column Injury
1
1
Strangulation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Breg Inc
II
Nov-03-2023
2
Compass Health Brands (Corporate Office)
II
Jan-19-2022
3
Invacare Corporation
II
Aug-23-2023
4
James Leckey Design Ltd
II
May-27-2021
5
Medical Depot Inc.
II
Jul-12-2024
6
Nova Ortho-Med Inc
II
Oct-17-2024
7
Nova Ortho-Med Inc
II
Dec-21-2020
8
R82 A/S
II
May-04-2020
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