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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
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
103
103
Fracture
49
49
Mechanical Problem
47
47
Adverse Event Without Identified Device or Use Problem
45
45
Appropriate Term/Code Not Available
45
45
Insufficient Information
31
31
Material Integrity Problem
23
23
Use of Device Problem
22
22
Unintended Movement
20
20
Material Twisted/Bent
18
18
Detachment of Device or Device Component
17
17
Material Fragmentation
15
15
Sharp Edges
13
13
Collapse
13
13
Solder Joint Fracture
11
11
Defective Component
7
7
Improper or Incorrect Procedure or Method
7
7
Crack
5
5
Patient Device Interaction Problem
4
4
Loose or Intermittent Connection
4
4
Off-Label Use
4
4
Component Missing
4
4
Device Dislodged or Dislocated
4
4
Failure to Align
4
4
Device Fell
3
3
Device Damaged Prior to Use
3
3
Device Slipped
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Unintended System Motion
3
3
Material Protrusion/Extrusion
2
2
Naturally Worn
2
2
Material Deformation
2
2
Device Unsafe to Use in Environment
2
2
Material Separation
2
2
Defective Device
2
2
Product Quality Problem
2
2
Material Frayed
2
2
Protective Measures Problem
2
2
No Apparent Adverse Event
2
2
Unintended Collision
2
2
Structural Problem
2
2
Human-Device Interface Problem
2
2
Unstable
2
2
Mechanical Jam
2
2
Connection Problem
1
1
Failure to Advance
1
1
Separation Problem
1
1
Misassembled During Installation
1
1
Self-Activation or Keying
1
1
Misassembly by Users
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
211
211
Laceration(s)
99
99
Bone Fracture(s)
86
86
No Clinical Signs, Symptoms or Conditions
43
43
Bruise/Contusion
43
43
Head Injury
41
41
Pain
28
28
Insufficient Information
25
25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
16
Limb Fracture
15
15
Concussion
14
14
Hip Fracture
14
14
Damage to Ligament(s)
10
10
Easy Bruising
10
10
Vertebral Fracture
8
8
Abrasion
7
7
Swelling/ Edema
6
6
Joint Dislocation
6
6
Muscle/Tendon Damage
5
5
Hemorrhage/Bleeding
5
5
Neck Pain
5
5
Skin Tears
5
5
No Consequences Or Impact To Patient
4
4
Injury
4
4
Brain Injury
4
4
No Known Impact Or Consequence To Patient
4
4
Hematoma
3
3
Tooth Fracture
3
3
Unspecified Tissue Injury
3
3
Headache
2
2
Multiple Fractures
2
2
Cognitive Changes
1
1
Stroke/CVA
1
1
Erythema
1
1
Eye Injury
1
1
Ambulation Difficulties
1
1
Post Traumatic Wound Infection
1
1
Sweating
1
1
Loss of consciousness
1
1
Coma
1
1
Non-union Bone Fracture
1
1
Skin Infection
1
1
Drug Resistant Bacterial Infection
1
1
Fracture, Arm
1
1
Physical Entrapment
1
1
Convulsion/Seizure
1
1
Balance Problems
1
1
Memory Loss/Impairment
1
1
Myocardial Infarction
1
1
Patient Problem/Medical Problem
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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