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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device retractor
Product CodeGAD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 90 90
2018 77 77
2019 62 62
2020 86 86
2021 81 81
2022 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
Break 153 153
Crack 36 36
Device-Device Incompatibility 32 32
Adverse Event Without Identified Device or Use Problem 31 31
Detachment of Device or Device Component 30 30
Material Deformation 21 21
Fracture 19 19
Material Twisted/Bent 16 16
Mechanical Jam 12 12
Compatibility Problem 12 12
Detachment Of Device Component 12 12
Mechanical Problem 10 10
Material Integrity Problem 10 10
Difficult to Remove 9 9
Component Missing 9 9
Device Operates Differently Than Expected 8 8
Appropriate Term/Code Not Available 7 7
Material Fragmentation 6 6
Material Separation 5 5
Device Slipped 5 5
Positioning Problem 5 5
Use of Device Problem 5 5
Contamination /Decontamination Problem 4 4
Difficult to Open or Close 4 4
Scratched Material 4 4
Mechanics Altered 4 4
Disassembly 3 3
Entrapment of Device 2 2
Difficult to Insert 2 2
Component Falling 2 2
Device Reprocessing Problem 2 2
Failure To Adhere Or Bond 2 2
Sticking 2 2
Difficult or Delayed Positioning 2 2
Product Quality Problem 2 2
Naturally Worn 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Device Difficult to Maintain 2 2
Device Dislodged or Dislocated 2 2
Fitting Problem 2 2
Insufficient Information 2 2
Excessive Heating 2 2
Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Activation, Positioning or Separation Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fail-Safe Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Difficult to Open or Remove Packaging Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Distortion 1 1
No Apparent Adverse Event 1 1
Packaging Problem 1 1
Sharp Edges 1 1
Device Fell 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Unintended Movement 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
No Device Output 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Shipping Damage or Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Align 1 1
Failure to Advance 1 1
Defective Device 1 1
Bent 1 1
Degraded 1 1
Inadequate Instructions for Healthcare Professional 1 1
Leak/Splash 1 1
Material Erosion 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 139 139
No Consequences Or Impact To Patient 90 90
No Known Impact Or Consequence To Patient 73 73
No Patient Involvement 52 52
No Information 18 18
Device Embedded In Tissue or Plaque 16 16
Foreign Body In Patient 16 16
Insufficient Information 13 13
No Code Available 13 13
Injury 9 9
Hemorrhage/Bleeding 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Hematoma 4 4
Pain 4 4
Tissue Damage 4 4
Blood Loss 4 4
Skin Tears 3 3
Liver Damage/Dysfunction 3 3
Necrosis 2 2
Bone Fracture(s) 2 2
Burn(s) 2 2
Burn, Thermal 2 2
Bowel Perforation 2 2
Superficial (First Degree) Burn 2 2
Numbness 2 2
Post Operative Wound Infection 2 2
Not Applicable 2 2
Unspecified Heart Problem 1 1
Blister 1 1
Unintended Radiation Exposure 1 1
Shaking/Tremors 1 1
Joint Dislocation 1 1
Osteolysis 1 1
Vertigo 1 1
Vomiting 1 1
Ulcer 1 1
Discomfort 1 1
Patient Problem/Medical Problem 1 1
Cognitive Changes 1 1
Weight Changes 1 1
Death 1 1
Exsanguination 1 1
Pulmonary Embolism 1 1
Abdominal Pain 1 1
Atrial Fibrillation 1 1
Granuloma 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Neuropathy 1 1
Muscle Weakness 1 1
Nausea 1 1
Perforation 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Seroma 1 1
Swelling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AAP Implantate Ag II Apr-06-2020
2 CooperSurgical, Inc. II Sep-27-2018
3 Smith & Nephew, Inc. II Aug-17-2020
4 Synthes (USA) Products LLC II May-09-2018
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