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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 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Break 108 108
Mechanical Problem 54 54
Appropriate Term/Code Not Available 51 51
Fracture 50 50
Adverse Event Without Identified Device or Use Problem 46 46
Insufficient Information 38 38
Material Integrity Problem 24 24
Use of Device Problem 23 23
Unintended Movement 20 20
Detachment of Device or Device Component 19 19
Material Twisted/Bent 19 19
Material Fragmentation 15 15
Collapse 14 14
Sharp Edges 13 13
Solder Joint Fracture 11 11
Improper or Incorrect Procedure or Method 7 7
Defective Component 7 7
Crack 5 5
Loose or Intermittent Connection 5 5
Device Dislodged or Dislocated 4 4
Off-Label Use 4 4
Patient Device Interaction Problem 4 4
Failure to Align 4 4
Component Missing 4 4
Unintended System Motion 3 3
Material Separation 3 3
Structural Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Fell 3 3
Device Damaged Prior to Use 3 3
Device Slipped 3 3
Defective Device 2 2
Device Unsafe to Use in Environment 2 2
Material Deformation 2 2
Misassembly by Users 2 2
Naturally Worn 2 2
Product Quality Problem 2 2
Mechanical Jam 2 2
Unintended Collision 2 2
Material Protrusion/Extrusion 2 2
No Apparent Adverse Event 2 2
Human-Device Interface Problem 2 2
Unstable 2 2
Protective Measures Problem 2 2
Material Frayed 2 2
Self-Activation or Keying 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Inadequate User Interface 1 1
Connection Problem 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 221 221
Laceration(s) 101 101
Bone Fracture(s) 95 95
Bruise/Contusion 45 45
No Clinical Signs, Symptoms or Conditions 44 44
Head Injury 41 41
Pain 32 32
Insufficient Information 26 26
Limb Fracture 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Hip Fracture 15 15
Concussion 15 15
Damage to Ligament(s) 12 12
Easy Bruising 10 10
Vertebral Fracture 8 8
Joint Dislocation 8 8
Abrasion 7 7
Hemorrhage/Bleeding 6 6
Swelling/ Edema 6 6
Brain Injury 5 5
Muscle/Tendon Damage 5 5
Neck Pain 5 5
Skin Tears 5 5
No Consequences Or Impact To Patient 4 4
Hematoma 4 4
No Known Impact Or Consequence To Patient 4 4
Injury 4 4
Unspecified Tissue Injury 3 3
Tooth Fracture 3 3
Multiple Fractures 2 2
Headache 2 2
Non-union Bone Fracture 1 1
Convulsion/Seizure 1 1
Eye Injury 1 1
Myocardial Infarction 1 1
Loss of Vision 1 1
Physical Entrapment 1 1
Coma 1 1
Loss of consciousness 1 1
Bacterial Infection 1 1
Ambulation Difficulties 1 1
Scar Tissue 1 1
Balance Problems 1 1
Erythema 1 1
Strangulation 1 1
No Patient Involvement 1 1
Vertigo 1 1
Thrombosis/Thrombus 1 1
Foreign Body In Patient 1 1
Post Traumatic Wound 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
7 Nova Ortho-Med Inc II Dec-21-2020
8 R82 A/S II May-04-2020
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