• 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 floss, dental
Product CodeJES
Regulation Number 872.6390
Device Class 1

MDR Year MDR Reports MDR Events
2017 50 50
2018 52 52
2019 52 52
2020 32 32
2021 32 32
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 63 63
Adverse Event Without Identified Device or Use Problem 52 52
Detachment of Device or Device Component 40 40
Detachment Of Device Component 17 17
Insufficient Information 10 10
Patient-Device Incompatibility 8 8
Product Quality Problem 6 6
Material Fragmentation 5 5
Physical Resistance/Sticking 5 5
Entrapment of Device 4 4
Use of Device Problem 4 4
Material Separation 3 3
Sharp Edges 3 3
Patient Device Interaction Problem 2 2
Device Markings/Labelling Problem 2 2
Device Operates Differently Than Expected 2 2
Device Dislodged or Dislocated 2 2
Material Integrity Problem 2 2
Material Frayed 2 2
Improper or Incorrect Procedure or Method 2 2
Difficult to Remove 2 2
Material Too Rigid or Stiff 1 1
Defective Component 1 1
Structural Problem 1 1
Crack 1 1
Failure to Select Signal 1 1
Device Slipped 1 1
Sticking 1 1
Material Twisted/Bent 1 1
Human-Device Interface Problem 1 1
Incorrect Device Or Component Shipped 1 1
Device Damaged by Another Device 1 1
Device Fell 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 69 69
No Consequences Or Impact To Patient 30 30
No Code Available 27 27
Foreign Body In Patient 24 24
Tooth Fracture 23 23
No Clinical Signs, Symptoms or Conditions 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Pain 8 8
Swelling 8 8
Hypersensitivity/Allergic reaction 8 8
Inflammation 6 6
Reaction 6 6
Insufficient Information 6 6
No Information 5 5
Sensitivity of Teeth 4 4
Unspecified Infection 3 3
Discomfort 3 3
Device Embedded In Tissue or Plaque 3 3
Laceration(s) 3 3
Injury 2 2
Numbness 2 2
Malaise 1 1
Pharyngitis 1 1
Choking 1 1
Syncope/Fainting 1 1
Skin Burning Sensation 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Nausea 1 1
Wheal(s) 1 1
Urticaria 1 1
Vomiting 1 1
Radiation Underdose 1 1
Irritation 1 1
Itching Sensation 1 1
Failure of Implant 1 1
Abscess 1 1
Angina 1 1
Dyspnea 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1

-
-