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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 258 258

Device Problems MDRs with this Device Problem Events in those MDRs
Break 143 144
Mechanical Problem 107 107
Appropriate Term/Code Not Available 74 74
Fracture 62 62
Insufficient Information 59 59
Material Integrity Problem 47 47
Material Twisted/Bent 36 36
Detachment of Device or Device Component 34 34
Unintended Movement 31 31
Adverse Event Without Identified Device or Use Problem 31 31
No Apparent Adverse Event 26 26
Use of Device Problem 19 19
Sharp Edges 15 15
Defective Component 13 13
Loose or Intermittent Connection 11 11
Collapse 11 11
Unstable 9 9
Crack 7 7
Material Deformation 7 7
Solder Joint Fracture 7 7
Device Slipped 6 6
Improper or Incorrect Procedure or Method 6 6
Material Separation 6 6
Defective Device 6 6
Component Missing 6 6
Protective Measures Problem 4 4
Structural Problem 4 4
Patient Device Interaction Problem 4 4
Mechanical Jam 3 3
Naturally Worn 3 3
Unintended System Motion 3 3
Device Dislodged or Dislocated 3 3
Device Handling Problem 3 3
Mechanics Altered 3 3
Failure to Align 3 3
Material Fragmentation 3 3
Degraded 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Fell 3 3
Physical Resistance/Sticking 3 3
Off-Label Use 3 3
Material Split, Cut or Torn 3 3
Fail-Safe Problem 2 2
Fail-Safe Did Not Operate 2 2
Device Unsafe to Use in Environment 2 2
Misassembly by Users 2 2
Product Quality Problem 2 2
Device Damaged Prior to Use 2 2
Material Protrusion/Extrusion 2 2
Connection Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 231 231
No Clinical Signs, Symptoms or Conditions 222 222
Bone Fracture(s) 108 108
Laceration(s) 97 97
Pain 49 49
Bruise/Contusion 47 47
Head Injury 34 35
Insufficient Information 33 33
Concussion 19 19
Limb Fracture 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Damage to Ligament(s) 15 15
Hip Fracture 15 15
Vertebral Fracture 13 13
Abrasion 12 12
Easy Bruising 10 10
Muscle/Tendon Damage 10 10
Swelling/ Edema 9 9
Joint Dislocation 9 9
Brain Injury 7 7
Hemorrhage/Bleeding 6 6
Unspecified Tissue Injury 5 5
Hematoma 4 4
Multiple Fractures 4 4
Convulsion/Seizure 4 4
Skin Tears 4 4
Tooth Fracture 3 3
Post Traumatic Wound Infection 3 3
Headache 3 3
Discomfort 3 3
Memory Loss/Impairment 2 2
Skull Fracture 2 2
Unspecified Musculoskeletal problem 2 2
Loss of consciousness 2 2
Neck Pain 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Hernia 2 2
Scar Tissue 2 2
Ambulation Difficulties 1 1
Deformity/ Disfigurement 1 1
Loss of Vision 1 1
Bacterial Infection 1 1
Myocardial Infarction 1 1
Non-union Bone Fracture 1 1
Eye Injury 1 1
Unspecified Infection 1 1
Balance Problems 1 1
Coma 1 1
Ecchymosis 1 1
Skin 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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