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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
2019 62 62
2020 86 86
2021 81 81
2022 80 80
2023 80 80
2024 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Break 152 152
Device-Device Incompatibility 45 45
Crack 39 39
Detachment of Device or Device Component 35 35
Material Integrity Problem 30 30
Compatibility Problem 25 25
Material Twisted/Bent 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Mechanical Jam 13 13
Fracture 12 12
Contamination /Decontamination Problem 10 10
Material Deformation 10 10
Mechanical Problem 9 9
Difficult to Remove 9 9
Component Missing 7 7
Corroded 6 6
Mechanics Altered 5 5
Patient Device Interaction Problem 4 4
Material Fragmentation 4 4
Device Slipped 4 4
Use of Device Problem 3 3
Device Dislodged or Dislocated 3 3
Material Separation 3 3
Material Split, Cut or Torn 3 3
Positioning Problem 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Excessive Heating 2 2
Scratched Material 2 2
Physical Resistance/Sticking 2 2
Fitting Problem 2 2
Device Difficult to Maintain 2 2
Difficult to Insert 2 2
Entrapment of Device 2 2
Positioning Failure 2 2
Difficult to Open or Close 2 2
Difficult to Open or Remove Packaging Material 1 1
Device Markings/Labelling Problem 1 1
Fail-Safe Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Defective Device 1 1
Material Discolored 1 1
Material Erosion 1 1
Shipping Damage or Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
No Device Output 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
No Apparent Adverse Event 1 1
Sharp Edges 1 1
Device Fell 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Naturally Worn 1 1
Separation Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 263 263
No Consequences Or Impact To Patient 60 60
No Patient Involvement 24 24
Insufficient Information 20 20
No Known Impact Or Consequence To Patient 19 19
Foreign Body In Patient 13 13
Device Embedded In Tissue or Plaque 7 7
No Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Code Available 6 6
Bone Fracture(s) 5 5
Liver Damage/Dysfunction 4 4
Cancer 4 4
Pain 3 3
Hemorrhage/Bleeding 3 3
Liver Laceration(s) 3 3
Perforation of Vessels 3 3
Laceration(s) 2 2
Abdominal Pain 2 2
Necrosis 2 2
Burn, Thermal 2 2
Blister 1 1
Injury 1 1
Granuloma 1 1
Blood Loss 1 1
Numbness 1 1
Wound Dehiscence 1 1
Unspecified Heart Problem 1 1
Exsanguination 1 1
Hematoma 1 1
Osteolysis 1 1
Unspecified Tissue Injury 1 1
Death 1 1
Tissue Damage 1 1
Not Applicable 1 1
Spinal Cord Injury 1 1
Unintended Radiation Exposure 1 1
Post Operative Wound Infection 1 1
Muscle/Tendon Damage 1 1
Superficial (First Degree) Burn 1 1
Failure of Implant 1 1
Joint Dislocation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AAP Implantate Ag II Apr-06-2020
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
3 Medagent Inc II Feb-23-2024
4 Medtronic Navigation, Inc. II Jan-12-2023
5 Smith & Nephew, Inc. II Aug-17-2020
6 TELEFLEX LLC II Jul-05-2023
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