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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device walker, mechanical
Product CodeITJ
Regulation Number 890.3825
Device Class 1

MDR Year MDR Reports MDR Events
2019 114 114
2020 117 117
2021 81 81
2022 114 114
2023 140 140
2024 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Break 126 126
Adverse Event Without Identified Device or Use Problem 61 61
Fracture 54 54
Appropriate Term/Code Not Available 43 43
Mechanical Problem 34 34
Insufficient Information 29 29
Use of Device Problem 28 28
Detachment of Device or Device Component 26 26
Unintended Movement 25 25
Material Integrity Problem 24 24
Collapse 23 23
Material Fragmentation 23 23
Material Twisted/Bent 20 20
Solder Joint Fracture 15 15
Sharp Edges 14 14
Device Slipped 11 11
Defective Component 8 8
Improper or Incorrect Procedure or Method 7 7
Crack 6 6
Material Separation 6 6
Device Dislodged or Dislocated 5 5
Device Fell 5 5
Component Missing 5 5
Loose or Intermittent Connection 4 4
Failure to Align 4 4
Patient Device Interaction Problem 4 4
Device Damaged Prior to Use 4 4
Device Tipped Over 4 4
Off-Label Use 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Defective Device 3 3
Device Unsafe to Use in Environment 3 3
Unintended System Motion 3 3
Human-Device Interface Problem 3 3
Unstable 3 3
Misassembled During Installation 2 2
Structural Problem 2 2
Material Deformation 2 2
Device Handling Problem 2 2
Product Quality Problem 2 2
Material Protrusion/Extrusion 2 2
No Apparent Adverse Event 2 2
Protective Measures Problem 2 2
Naturally Worn 2 2
Material Frayed 2 2
Mechanical Jam 2 2
Unintended Collision 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Degraded 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 257 257
Bone Fracture(s) 107 107
Laceration(s) 105 105
Bruise/Contusion 52 52
Head Injury 43 43
No Clinical Signs, Symptoms or Conditions 42 42
Pain 32 32
Insufficient Information 23 23
Hip Fracture 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Limb Fracture 13 13
Concussion 13 13
Injury 12 12
No Known Impact Or Consequence To Patient 11 11
Easy Bruising 10 10
Damage to Ligament(s) 8 8
Vertebral Fracture 8 8
Fracture, Arm 7 7
Joint Dislocation 7 7
Abrasion 7 7
Swelling/ Edema 6 6
Neck Pain 6 6
No Consequences Or Impact To Patient 5 5
Skin Tears 5 5
Muscle/Tendon Damage 5 5
Brain Injury 4 4
Hematoma 4 4
Tooth Fracture 4 4
Unspecified Tissue Injury 3 3
Loss of consciousness 2 2
Hemorrhage/Bleeding 2 2
Headache 2 2
No Patient Involvement 2 2
Spinal Column Injury 2 2
Contusion 2 2
Multiple Fractures 2 2
No Code Available 2 2
Patient Problem/Medical Problem 2 2
Strangulation 1 1
Vertigo 1 1
Loss of Range of Motion 1 1
Erythema 1 1
Chest Pain 1 1
Foreign Body In Patient 1 1
Hemorrhage, Cerebral 1 1
Post Traumatic Wound Infection 1 1
Scar Tissue 1 1
Balance Problems 1 1
Eye Injury 1 1
Physical Entrapment 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 Dec-21-2020
7 R82 A/S II May-04-2020
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