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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 103 103
Fracture 49 49
Mechanical Problem 47 47
Adverse Event Without Identified Device or Use Problem 45 45
Appropriate Term/Code Not Available 45 45
Insufficient Information 31 31
Material Integrity Problem 23 23
Use of Device Problem 22 22
Unintended Movement 20 20
Material Twisted/Bent 18 18
Detachment of Device or Device Component 17 17
Material Fragmentation 15 15
Sharp Edges 13 13
Collapse 13 13
Solder Joint Fracture 11 11
Defective Component 7 7
Improper or Incorrect Procedure or Method 7 7
Crack 5 5
Patient Device Interaction Problem 4 4
Loose or Intermittent Connection 4 4
Off-Label Use 4 4
Component Missing 4 4
Device Dislodged or Dislocated 4 4
Failure to Align 4 4
Device Fell 3 3
Device Damaged Prior to Use 3 3
Device Slipped 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Unintended System Motion 3 3
Material Protrusion/Extrusion 2 2
Naturally Worn 2 2
Material Deformation 2 2
Device Unsafe to Use in Environment 2 2
Material Separation 2 2
Defective Device 2 2
Product Quality Problem 2 2
Material Frayed 2 2
Protective Measures Problem 2 2
No Apparent Adverse Event 2 2
Unintended Collision 2 2
Structural Problem 2 2
Human-Device Interface Problem 2 2
Unstable 2 2
Mechanical Jam 2 2
Connection Problem 1 1
Failure to Advance 1 1
Separation Problem 1 1
Misassembled During Installation 1 1
Self-Activation or Keying 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 211 211
Laceration(s) 99 99
Bone Fracture(s) 86 86
No Clinical Signs, Symptoms or Conditions 43 43
Bruise/Contusion 43 43
Head Injury 41 41
Pain 28 28
Insufficient Information 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Limb Fracture 15 15
Concussion 14 14
Hip Fracture 14 14
Damage to Ligament(s) 10 10
Easy Bruising 10 10
Vertebral Fracture 8 8
Abrasion 7 7
Swelling/ Edema 6 6
Joint Dislocation 6 6
Muscle/Tendon Damage 5 5
Hemorrhage/Bleeding 5 5
Neck Pain 5 5
Skin Tears 5 5
No Consequences Or Impact To Patient 4 4
Injury 4 4
Brain Injury 4 4
No Known Impact Or Consequence To Patient 4 4
Hematoma 3 3
Tooth Fracture 3 3
Unspecified Tissue Injury 3 3
Headache 2 2
Multiple Fractures 2 2
Cognitive Changes 1 1
Stroke/CVA 1 1
Erythema 1 1
Eye Injury 1 1
Ambulation Difficulties 1 1
Post Traumatic Wound Infection 1 1
Sweating 1 1
Loss of consciousness 1 1
Coma 1 1
Non-union Bone Fracture 1 1
Skin Infection 1 1
Drug Resistant Bacterial Infection 1 1
Fracture, Arm 1 1
Physical Entrapment 1 1
Convulsion/Seizure 1 1
Balance Problems 1 1
Memory Loss/Impairment 1 1
Myocardial Infarction 1 1
Patient Problem/Medical Problem 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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