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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device walker, mechanical
Regulation Description Mechanical walker.
Product CodeITJ
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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