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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
2014 2782 2782
2015 1122 1122
2016 499 499
2017 131 131
2018 126 126
2019 114 114
2020 117 117
2021 81 81
2022 114 114
2023 140 140
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1609 1609
Unstable 833 833
Device Slipped 429 429
Crack 281 281
Product Quality Problem 273 273
Detachment Of Device Component 244 244
Bent 241 241
Device Operates Differently Than Expected 239 239
Adverse Event Without Identified Device or Use Problem 139 139
Mechanical Problem 116 116
Unintended Movement 93 93
Naturally Worn 91 91
Device Inoperable 90 90
Out-Of-Box Failure 86 86
Collapse 83 83
Fracture 74 74
Insufficient Information 74 74
Component Falling 73 73
Device Dislodged or Dislocated 59 59
Detachment of Device or Device Component 57 57
Component Missing 46 46
Loose or Intermittent Connection 45 45
Material Integrity Problem 45 45
Use of Device Problem 44 44
Appropriate Term/Code Not Available 33 33
Material Separation 29 29
Mechanical Jam 28 28
Sticking 27 27
Solder Joint Fracture 26 26
Material Protrusion/Extrusion 25 25
Material Twisted/Bent 24 24
Material Fragmentation 24 24
Device Tipped Over 21 21
Improper or Incorrect Procedure or Method 21 21
Deformation Due to Compressive Stress 20 20
Defective Component 18 18
Split 16 16
Defective Device 13 13
Material Deformation 12 12
Mechanics Altered 12 12
Torn Material 12 12
Sharp Edges 12 12
Device Damaged Prior to Use 10 10
Failure to Align 7 7
Difficult to Fold, Unfold or Collapse 7 7
Noise, Audible 7 7
Device Unsafe to Use in Environment 6 6
Material Disintegration 6 6
Material Frayed 5 5
Unintended Collision 5 5
Patient Device Interaction Problem 5 5
Device Fell 5 5
Device Handling Problem 4 4
Protective Measures Problem 4 4
Unintended System Motion 4 4
Off-Label Use 4 4
Device Maintenance Issue 4 4
Bolus mechanism failure 4 4
Device Issue 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Connection Problem 3 3
Folded 3 3
Structural Problem 3 3
Hole In Material 3 3
Misassembled 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Positioning Problem 3 3
Misassembly by Users 3 3
Human-Device Interface Problem 3 3
No Apparent Adverse Event 2 2
Physical Property Issue 2 2
Misassembled During Installation 2 2
Peeled/Delaminated 2 2
Difficult To Position 2 2
Degraded 2 2
Entrapment of Device 2 2
Failure to Advance 2 2
Dent in Material 2 2
Device Displays Incorrect Message 2 2
Fitting Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Too Rigid or Stiff 2 2
Self-Activation or Keying 1 1
Inadequate Service 1 1
Device Stops Intermittently 1 1
Vibration 1 1
Incomplete or Missing Packaging 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Date/Time-Related Software Problem 1 1
Fail-Safe Design Failure 1 1
Fire 1 1
Disassembly 1 1
Partial Blockage 1 1
Accessory Incompatible 1 1
Device Alarm System 1 1
Migration or Expulsion of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Function indicator light(s), failure of 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2631 2631
No Known Impact Or Consequence To Patient 1283 1283
Fall 659 659
Bone Fracture(s) 199 199
Laceration(s) 152 152
Bruise/Contusion 120 120
Injury 107 107
No Information 94 94
Head Injury 80 80
Pain 48 48
Hip Fracture 41 41
No Clinical Signs, Symptoms or Conditions 33 33
Insufficient Information 23 23
Fracture, Arm 23 23
Abrasion 22 22
Discomfort 20 20
No Patient Involvement 20 20
Concussion 19 19
Skin Tears 16 16
Limb Fracture 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Easy Bruising 10 10
Contusion 10 10
Hematoma 9 9
Joint Dislocation 9 9
No Code Available 9 9
Tooth Fracture 8 8
Neck Pain 7 7
Spinal Column Injury 7 7
Damage to Ligament(s) 7 7
Death 7 7
Vertebral Fracture 7 7
Brain Injury 6 6
Complaint, Ill-Defined 5 5
Hemorrhage/Bleeding 5 5
Unspecified Infection 5 5
Muscle/Tendon Damage 5 5
Swelling/ Edema 5 5
Patient Problem/Medical Problem 5 5
Ambulation Difficulties 4 4
Headache 4 4
Loss of consciousness 4 4
Skull Fracture 4 4
Swelling 4 4
Tissue Damage 3 3
Rupture 3 3
Radiation Underdose 3 3
Wound Dehiscence 3 3
Post Traumatic Wound Infection 3 3
Lymphoma 3 3
Unspecified Tissue Injury 3 3
Foreign Body In Patient 2 2
Multiple Fractures 2 2
Suture Abrasion 2 2
Eye Injury 2 2
Intracranial Hemorrhage 2 2
Hemorrhage, Subdural 2 2
Pyrosis/Heartburn 2 2
Urinary Retention 2 2
Loss of Vision 2 2
Sprain 2 2
Disability 2 2
Physical Entrapment 2 2
Non-union Bone Fracture 1 1
Ventilator Dependent 1 1
Sensitivity of Teeth 1 1
Sweating 1 1
Strangulation 1 1
Soreness 1 1
Ulceration 1 1
Thrombus 1 1
Weakness 1 1
Vertigo 1 1
Inflammation 1 1
Hemorrhage, Cerebral 1 1
Memory Loss/Impairment 1 1
Muscle Spasm(s) 1 1
Pneumonia 1 1
Loss of Range of Motion 1 1
Scar Tissue 1 1
Sepsis 1 1
Shock 1 1
Hearing Loss 1 1
Bleeding 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Dehydration 1 1
Dyspnea 1 1
Ecchymosis 1 1
Edema 1 1
Emotional Changes 1 1
Erythema 1 1
Sleep Dysfunction 1 1
Cognitive Changes 1 1
Hematuria 1 1
Disc Impingement 1 1
Fluid Discharge 1 1
Balance Problems 1 1
Skin Infection 1 1
Drug Resistant Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Breg Inc II Nov-03-2023
2 Briggs Medical Service Company d.b.a. Mabis II Oct-28-2014
3 Central Purchasing LLC DBA Harbor Freight Tools II Apr-10-2014
4 Compass Health Brands (Corporate Office) II Jan-19-2022
5 Essential Medical Supply, Inc. II Aug-25-2010
6 Essential Medical Supply, Inc. II Jul-20-2009
7 Etac Supply Center Ab II Jul-14-2012
8 Invacare Corporation II Aug-23-2023
9 Invacare Corporation II Jun-05-2012
10 Invacare Corporation II Sep-27-2011
11 James Leckey Design Ltd II May-27-2021
12 Nova Ortho-Med Inc II Dec-21-2020
13 Nova Ortho-Med Inc II Oct-24-2016
14 Owens & Minor Distribution, Inc. II Nov-20-2014
15 R82 A/S II May-04-2020
16 Roscoe Medical Inc II Nov-12-2014
17 SVS LLC II Nov-20-2018
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