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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 82
2022 114 114
2023 140 140
2024 84 84
2025 113 113

Device Problems MDRs with this Device Problem Events in those MDRs
Break 116 117
Mechanical Problem 70 70
Appropriate Term/Code Not Available 57 57
Fracture 51 51
Adverse Event Without Identified Device or Use Problem 50 50
Insufficient Information 43 43
Material Integrity Problem 26 26
Unintended Movement 25 25
Use of Device Problem 25 25
Detachment of Device or Device Component 22 22
Material Twisted/Bent 19 19
Sharp Edges 16 16
Material Fragmentation 15 15
Collapse 14 14
Solder Joint Fracture 13 13
Improper or Incorrect Procedure or Method 7 7
Crack 7 7
Defective Component 7 7
Device Slipped 6 6
Loose or Intermittent Connection 6 6
Off-Label Use 5 5
Device Dislodged or Dislocated 4 4
Failure to Align 4 4
Patient Device Interaction Problem 4 4
Component Missing 4 4
Product Quality Problem 3 3
Material Separation 3 3
Device Unsafe to Use in Environment 3 3
Structural Problem 3 3
Degraded 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Fell 3 3
Protective Measures Problem 3 3
Unintended System Motion 3 3
Device Damaged Prior to Use 3 3
Material Split, Cut or Torn 3 3
Mechanical Jam 3 3
Material Protrusion/Extrusion 2 2
No Apparent Adverse Event 2 2
Human-Device Interface Problem 2 2
Naturally Worn 2 2
Unintended Collision 2 2
Misassembly by Users 2 2
Material Deformation 2 2
Defective Device 2 2
Unstable 2 2
Material Frayed 2 2
Device Handling Problem 1 1
Fail-Safe Problem 1 1
Misassembled During Installation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 241 241
Bone Fracture(s) 114 114
Laceration(s) 109 109
Bruise/Contusion 50 50
No Clinical Signs, Symptoms or Conditions 50 50
Head Injury 41 42
Pain 33 33
Insufficient Information 29 29
Limb Fracture 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Concussion 16 16
Hip Fracture 15 15
Damage to Ligament(s) 14 14
Joint Dislocation 11 11
Abrasion 10 10
Easy Bruising 10 10
Vertebral Fracture 9 9
Hemorrhage/Bleeding 6 6
Skin Tears 6 6
Swelling/ Edema 6 6
Brain Injury 5 5
Muscle/Tendon Damage 5 5
Neck Pain 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
Multiple Fractures 3 3
Tooth Fracture 3 3
Headache 2 2
Convulsion/Seizure 2 2
Post Traumatic Wound Infection 2 2
Memory Loss/Impairment 2 2
Confusion/ Disorientation 1 1
Foreign Body In Patient 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Thrombosis/Thrombus 1 1
Erythema 1 1
Strangulation 1 1
Vertigo 1 1
Discomfort 1 1
No Patient Involvement 1 1
Spinal Column Injury 1 1
Cognitive Changes 1 1
Perforation 1 1
Inflammation 1 1
Scar Tissue 1 1
Coma 1 1
Balance Problems 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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