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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device toothbrush, manual
Product CodeEFW
Regulation Number 872.6855
Device Class 1

MDR Year MDR Reports MDR Events
2017 68 68
2018 109 109
2019 115 115
2020 113 113
2021 120 120
2022 315 315

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 302 302
Break 251 251
Product Quality Problem 90 90
Material Fragmentation 79 79
Detachment Of Device Component 51 51
Material Separation 29 29
Device Slipped 21 21
Improper or Incorrect Procedure or Method 20 20
Adverse Event Without Identified Device or Use Problem 18 18
Device Fell 15 15
Component Falling 14 14
Entrapment of Device 11 11
Material Disintegration 7 7
Loose or Intermittent Connection 7 7
Patient-Device Incompatibility 5 5
Physical Resistance/Sticking 5 5
Material Twisted/Bent 4 4
Device Dislodged or Dislocated 4 4
Defective Device 4 4
Material Integrity Problem 4 4
Difficult to Remove 4 4
Sticking 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Insufficient Information 3 3
Patient Device Interaction Problem 2 2
Material Protrusion/Extrusion 2 2
Device Operates Differently Than Expected 2 2
Peeled/Delaminated 2 2
Structural Problem 2 2
Material Too Rigid or Stiff 2 2
Bent 2 2
Fluid/Blood Leak 2 2
Unintended Ejection 1 1
Mechanical Problem 1 1
Device Inoperable 1 1
Device Damaged Prior to Use 1 1
Out-Of-Box Failure 1 1
Contamination /Decontamination Problem 1 1
Inadequate User Interface 1 1
Device Contaminated During Manufacture or Shipping 1 1
Naturally Worn 1 1
Output Problem 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 221 221
No Known Impact Or Consequence To Patient 209 209
No Clinical Signs, Symptoms or Conditions 92 92
Foreign Body In Patient 84 84
Choking 62 62
Device Embedded In Tissue or Plaque 42 42
No Code Available 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
No Information 18 18
Pain 16 16
Vomiting 8 8
No Consequences Or Impact To Patient 8 8
Hemorrhage/Bleeding 8 8
Cough 8 8
Discomfort 8 8
Laceration(s) 7 7
Swelling 7 7
Hypersensitivity/Allergic reaction 4 4
Injury 4 4
Reaction 4 4
Sensitivity of Teeth 3 3
Tooth Fracture 3 3
No Patient Involvement 3 3
Unspecified Tissue Injury 3 3
Dyspnea 3 3
Emotional Changes 2 2
Abscess 2 2
Unspecified Infection 2 2
Irritation 2 2
Anxiety 2 2
Burning Sensation 2 2
Respiratory Distress 2 2
Tissue Damage 2 2
Needle Stick/Puncture 2 2
Unspecified Gastrointestinal Problem 2 2
Complaint, Ill-Defined 2 2
Numbness 2 2
Collapse 1 1
Coma 1 1
Malaise 1 1
Depression 1 1
Sore Throat 1 1
Post Traumatic Wound Infection 1 1
Hypervolemia 1 1
Dysuria 1 1
Chemical Exposure 1 1
Stomatitis 1 1
Patient Problem/Medical Problem 1 1
Ulceration 1 1
Skin Discoloration 1 1
Suffocation 1 1
Tingling 1 1
Tachycardia 1 1
Thrombosis 1 1
Thrombus 1 1
Nausea 1 1
Perforation 1 1
Rash 1 1
Itching Sensation 1 1
Inflammation 1 1
Hemorrhage, Cerebral 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abrasion 1 1
Airway Obstruction 1 1
Asthma 1 1
Burn(s) 1 1
Eye Injury 1 1
Headache 1 1
Hemoptysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
2 Fridababy LLC II Jan-30-2020
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