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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
2021 81 82
2022 114 114
2023 140 140
2024 84 84
2025 134 134
2026 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Break 111 112
Mechanical Problem 79 79
Appropriate Term/Code Not Available 58 58
Insufficient Information 48 48
Fracture 45 45
Material Integrity Problem 32 32
Adverse Event Without Identified Device or Use Problem 30 30
Unintended Movement 21 21
Detachment of Device or Device Component 17 17
Use of Device Problem 15 15
Sharp Edges 15 15
Material Twisted/Bent 12 12
Collapse 10 10
Loose or Intermittent Connection 7 7
Solder Joint Fracture 7 7
Device Slipped 6 6
Crack 6 6
Defective Component 5 5
Improper or Incorrect Procedure or Method 4 4
Patient Device Interaction Problem 4 4
Material Split, Cut or Torn 3 3
Off-Label Use 3 3
Unintended System Motion 3 3
Protective Measures Problem 3 3
Device Dislodged or Dislocated 3 3
Device Fell 3 3
Degraded 3 3
Component Missing 3 3
Failure to Align 3 3
Mechanical Jam 2 2
Naturally Worn 2 2
Human-Device Interface Problem 2 2
Material Protrusion/Extrusion 2 2
Material Separation 2 2
Product Quality Problem 2 2
Material Deformation 2 2
Device Unsafe to Use in Environment 2 2
Structural Problem 2 2
Material Fragmentation 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Damaged Prior to Use 2 2
Material Frayed 2 2
Fail-Safe Problem 1 1
Misassembled During Installation 1 1
Misassembly by Users 1 1
Device Handling Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Device 1 1
Wrong Label 1 1
Fail-Safe Did Not Operate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 193 193
Bone Fracture(s) 101 101
Laceration(s) 96 96
No Clinical Signs, Symptoms or Conditions 49 49
Bruise/Contusion 42 42
Pain 34 34
Head Injury 33 34
Insufficient Information 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Limb Fracture 15 15
Concussion 15 15
Hip Fracture 15 15
Damage to Ligament(s) 14 14
Vertebral Fracture 12 12
Easy Bruising 10 10
Abrasion 9 9
Joint Dislocation 9 9
Brain Injury 7 7
Swelling/ Edema 7 7
Hemorrhage/Bleeding 6 6
Unspecified Tissue Injury 5 5
Muscle/Tendon Damage 5 5
Multiple Fractures 4 4
Hematoma 4 4
Skin Tears 4 4
Post Traumatic Wound Infection 3 3
Discomfort 3 3
Tooth Fracture 3 3
Neck Pain 2 2
Scar Tissue 2 2
Skull Fracture 2 2
Memory Loss/Impairment 2 2
Headache 2 2
Convulsion/Seizure 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Thrombosis/Thrombus 1 1
Unspecified Eye / Vision Problem 1 1
Ambulation Difficulties 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Foreign Body In Patient 1 1
Balance Problems 1 1
Unspecified Musculoskeletal problem 1 1
Skin Infection 1 1
Drug Resistant Bacterial Infection 1 1
Stroke/CVA 1 1
Erythema 1 1
Eye Injury 1 1
Myocardial Infarction 1 1
Unspecified Infection 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
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