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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
2019 115 115
2020 117 117
2021 81 82
2022 114 114
2023 140 140
2024 84 84
2025 134 134
2026 438 438

Device Problems MDRs with this Device Problem Events in those MDRs
Break 174 174
Mechanical Problem 129 129
Fracture 91 91
Appropriate Device Problem Term/Code Not Available 79 79
Insufficient Device Problem Information 78 78
Material Integrity Problem 59 59
Material Twisted/Bent 59 59
Adverse Event Without Identified Device or Use Problem 51 51
Detachment of Device or Device Component 50 50
Unintended Movement 45 45
No Apparent Adverse Event 36 36
Use of Device Problem 32 32
Material Fragmentation 23 23
Solder Joint Fracture 19 19
Sharp Edges 16 16
Collapse 14 14
Material Separation 14 14
Loose or Intermittent Connection 12 12
Defective Component 12 12
Unstable 12 12
Damaged Thread 11 11
Device Slipped 11 11
Crack 10 10
Mechanics Altered 9 9
Material Deformation 7 7
Improper or Incorrect Procedure or Method 7 7
Defective Device 6 6
Structural Problem 6 6
Off-Label Use 5 5
Component Missing 5 5
Device Tipped Over 4 4
Failure to Align 4 4
Device Dislodged or Dislocated 4 4
Human-Device Interface Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Damaged Prior to Use 4 4
Device Handling Problem 4 4
Physical Resistance/Sticking 4 4
Unintended System Motion 3 3
Material Split, Cut or Torn 3 3
Patient Device Interaction Problem 3 3
Misassembly by Users 3 3
Naturally Worn 3 3
Mechanical Jam 3 3
Device Unsafe to Use in Environment 3 3
Connection Problem 3 3
Degraded 3 3
Material Frayed 3 3
Protective Measures Problem 2 2
Material Protrusion/Extrusion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 381 381
Fall 361 361
Bone Fracture(s) 159 159
Laceration(s) 129 129
Bruise/Contusion 68 68
Pain 60 60
Head Injury 49 50
Insufficient Information 37 37
Concussion 24 24
Hip Fracture 24 24
Limb Fracture 23 23
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 17 17
Damage to Ligament(s) 15 15
Abrasion 14 14
Vertebral Fracture 13 13
Joint Dislocation 12 12
Injury 12 12
No Known Impact Or Consequence To Patient 12 12
Muscle/Tendon Damage 12 12
Easy Bruising 10 10
Swelling/ Edema 9 9
Back pain 8 8
Fracture, Arm 7 7
Unspecified Tissue Injury 7 7
Brain Injury 7 7
Skin Tears 6 6
Discomfort 6 6
Hemorrhage/Blood Loss/Bleeding 6 6
Neck Pain 6 6
Limb Pain 5 5
Hematoma 5 5
No Consequences Or Impact To Patient 5 5
Tooth Fracture 5 5
Wound Infection 4 4
Convulsion/Seizure 4 4
Multiple Fractures 4 4
Loss of consciousness 3 3
Headache 3 3
Spinal Column Injury 2 2
Ecchymosis 2 2
Contusion 2 2
Memory Loss/Impairment 2 2
No Patient Involvement 2 2
Patient Problem/Medical Problem 2 2
No Code Available 2 2
Chest Pain 2 2
Scar Tissue 2 2
Hernia 2 2
Skull Fracture 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2

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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