• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device walker, mechanical
Regulation Description Mechanical walker.
Product CodeITJ
Regulation Number 890.3825
Device Class 1

MDR Year MDR Reports MDR Events
2016 499 499
2017 131 131
2018 125 125
2019 114 114
2020 117 117
2021 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Break 294 294
Device Slipped 137 137
Adverse Event Without Identified Device or Use Problem 89 89
Collapse 61 61
Detachment Of Device Component 59 59
Mechanical Problem 38 38
Detachment of Device or Device Component 38 38
Device Dislodged or Dislocated 36 36
Device Operates Differently Than Expected 35 35
Use of Device Problem 28 28
Component Falling 28 28
Fracture 26 26
Insufficient Information 26 26
Material Fragmentation 22 22
Solder Joint Fracture 22 22
Unintended Movement 22 22
Unstable 21 21
Material Integrity Problem 18 18
Bent 16 16
Crack 15 15
Material Twisted/Bent 13 13
Loose or Intermittent Connection 13 13
Device Tipped Over 12 12
Improper or Incorrect Procedure or Method 10 10
Defective Device 8 8
Material Separation 8 8
Component Missing 7 7
Sticking 6 6
Material Deformation 5 5
Device Unsafe to Use in Environment 4 4
Device Fell 4 4
Device Inoperable 4 4
Defective Component 4 4
Device Issue 4 4
Off-Label Use 4 4
Deformation Due to Compressive Stress 3 3
Material Protrusion/Extrusion 3 3
Device Damaged Prior to Use 3 3
Device Maintenance Issue 3 3
Unintended Collision 3 3
Connection Problem 3 3
Mechanics Altered 3 3
Sharp Edges 2 2
Product Quality Problem 2 2
Misassembly by Users 2 2
No Apparent Adverse Event 2 2
Folded 2 2
Structural Problem 2 2
Failure to Align 2 2
Split 2 2
Mechanical Jam 2 2
Naturally Worn 2 2
Physical Property Issue 2 2
Appropriate Term/Code Not Available 2 2
Device Handling Problem 2 2
Patient Device Interaction Problem 1 1
Misassembled During Installation 1 1
Protective Measures Problem 1 1
Torn Material 1 1
Device Operational Issue 1 1
Difficult to Open or Close 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Installation-Related Problem 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Patient-Device Incompatibility 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Service 1 1
Inadequacy of Device Shape and/or Size 1 1
Misassembled 1 1
Entrapment of Device 1 1
Accessory Incompatible 1 1
Failure to Advance 1 1
Device Displays Incorrect Message 1 1
Physical Resistance/Sticking 1 1
Positioning Problem 1 1
Material Distortion 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 414 414
Fall 322 322
Bone Fracture(s) 113 113
Injury 76 76
Laceration(s) 74 74
Bruise/Contusion 45 45
Head Injury 41 41
Hip Fracture 28 28
Pain 26 26
Fracture, Arm 19 19
No Consequences Or Impact To Patient 10 10
No Information 10 10
Contusion 8 8
Concussion 7 7
Hematoma 6 6
No Clinical Signs, Symptoms or Conditions 6 6
No Code Available 6 6
Limb Fracture 6 6
Patient Problem/Medical Problem 5 5
Tooth Fracture 5 5
Joint Dislocation 5 5
Spinal Column Injury 5 5
Neck Pain 4 4
Unspecified Infection 4 4
Death 4 4
Post Traumatic Wound Infection 3 3
Brain Injury 3 3
Skin Tears 3 3
Abrasion 3 3
Intracranial Hemorrhage 2 2
Swelling 2 2
Ambulation Difficulties 2 2
Muscle/Tendon Damage 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Rupture 2 2
Physical Entrapment 2 2
Loss of consciousness 2 2
Discomfort 2 2
Suture Abrasion 2 2
No Patient Involvement 2 2
Headache 2 2
Skull Fracture 2 2
Tissue Damage 1 1
Loss of Vision 1 1
Weakness 1 1
Pneumonia 1 1
Chest Pain 1 1
Hemorrhage, Subdural 1 1
Ecchymosis 1 1
Eye Injury 1 1
Disc Impingement 1 1
Disability 1 1
Sweating 1 1
Sleep Dysfunction 1 1
Vertigo 1 1
Wound Dehiscence 1 1
Sprain 1 1
Hemorrhage, Cerebral 1 1
Inflammation 1 1
Muscle Spasm(s) 1 1
Loss of Range of Motion 1 1
Dehydration 1 1
Emotional Changes 1 1
Hearing Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nova Ortho-Med Inc II Dec-21-2020
2 Nova Ortho-Med Inc II Oct-24-2016
3 R82 A/S II May-04-2020
4 SVS LLC II Nov-20-2018
-
-