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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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Break 121 121
Adverse Event Without Identified Device or Use Problem 61 61
Fracture 51 51
Appropriate Term/Code Not Available 31 31
Insufficient Information 28 28
Use of Device Problem 27 27
Detachment of Device or Device Component 26 26
Mechanical Problem 25 25
Unintended Movement 25 25
Material Fragmentation 23 23
Collapse 23 23
Material Integrity Problem 23 23
Material Twisted/Bent 19 19
Solder Joint Fracture 15 15
Sharp Edges 12 12
Device Slipped 11 11
Defective Component 7 7
Improper or Incorrect Procedure or Method 6 6
Crack 6 6
Material Separation 6 6
Device Fell 5 5
Device Dislodged or Dislocated 5 5
Device Tipped Over 4 4
Component Missing 4 4
Patient Device Interaction Problem 4 4
Failure to Align 4 4
Loose or Intermittent Connection 4 4
Device Damaged Prior to Use 4 4
Device Unsafe to Use in Environment 3 3
Defective Device 3 3
Off-Label Use 3 3
Unintended System Motion 3 3
Unstable 3 3
Human-Device Interface Problem 3 3
Misassembled During Installation 2 2
Product Quality Problem 2 2
No Apparent Adverse Event 2 2
Device Handling Problem 2 2
Material Protrusion/Extrusion 2 2
Mechanical Jam 2 2
Protective Measures Problem 2 2
Unintended Collision 2 2
Material Deformation 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Inadequate User Interface 1 1
Separation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Naturally Worn 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Physical Resistance/Sticking 1 1
Inadequacy of Device Shape and/or Size 1 1
Misassembly by Users 1 1
Difficult to Open or Close 1 1
Structural Problem 1 1
Degraded 1 1
Self-Activation or Keying 1 1
Material Frayed 1 1
Failure to Advance 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 252 252
Bone Fracture(s) 103 103
Laceration(s) 95 95
Bruise/Contusion 48 48
Head Injury 43 43
No Clinical Signs, Symptoms or Conditions 33 33
Pain 24 24
Insufficient Information 23 23
Hip Fracture 18 18
Limb Fracture 13 13
Injury 12 12
Concussion 11 11
No Known Impact Or Consequence To Patient 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Easy Bruising 10 10
Vertebral Fracture 7 7
Fracture, Arm 7 7
Joint Dislocation 7 7
Damage to Ligament(s) 7 7
Neck Pain 6 6
Abrasion 6 6
No Consequences Or Impact To Patient 5 5
Muscle/Tendon Damage 5 5
Swelling/ Edema 5 5
Skin Tears 4 4
Unspecified Tissue Injury 3 3
Brain Injury 3 3
Hematoma 3 3
Hemorrhage/Bleeding 2 2
Headache 2 2
Contusion 2 2
Spinal Column Injury 2 2
Multiple Fractures 2 2
No Patient Involvement 2 2
No Code Available 2 2
Tooth Fracture 2 2
Patient Problem/Medical Problem 2 2
Balance Problems 1 1
Foreign Body In Patient 1 1
Ambulation Difficulties 1 1
Cognitive Changes 1 1
Skin Infection 1 1
Drug Resistant Bacterial Infection 1 1
Strangulation 1 1
Vertigo 1 1
Loss of Vision 1 1
Physical Entrapment 1 1
Non-union Bone Fracture 1 1
Sweating 1 1
Post Traumatic Wound Infection 1 1
Loss of consciousness 1 1
Death 1 1
Erythema 1 1
Eye Injury 1 1
Hemorrhage, Cerebral 1 1
Chest Pain 1 1
Memory Loss/Impairment 1 1
Loss of Range of Motion 1 1
Scar Tissue 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 Nova Ortho-Med Inc II Dec-21-2020
6 R82 A/S II May-04-2020
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