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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


Premarket Reviews
ManufacturerDecision
BEAM TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTEK ORAL CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIAVE SPAZZOLIFICIO S.P.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 23 23
2015 48 48
2016 35 35
2017 68 68
2018 109 109
2019 115 115
2020 113 113
2021 120 120
2022 327 327
2023 99 99
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 345 345
Break 324 324
Product Quality Problem 128 128
Detachment Of Device Component 84 84
Material Fragmentation 80 80
Material Separation 35 35
Component Falling 29 29
Adverse Event Without Identified Device or Use Problem 27 27
Device Slipped 23 23
Improper or Incorrect Procedure or Method 22 22
Device Fell 15 15
Entrapment of Device 13 13
Material Disintegration 10 10
Device Operates Differently Than Expected 10 10
Patient-Device Incompatibility 9 9
Sticking 8 8
Loose or Intermittent Connection 8 8
Insufficient Information 8 8
Defective Device 7 7
Material Integrity Problem 7 7
Difficult to Remove 6 6
Device Dislodged or Dislocated 6 6
Physical Resistance/Sticking 5 5
Material Twisted/Bent 4 4
Device Contamination with Chemical or Other Material 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Human-Device Interface Problem 2 2
Out-Of-Box Failure 2 2
Structural Problem 2 2
Material Too Rigid or Stiff 2 2
Fluid/Blood Leak 2 2
Mechanical Problem 2 2
Peeled/Delaminated 2 2
Bent 2 2
Material Protrusion/Extrusion 2 2
No Apparent Adverse Event 2 2
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 2 2
Unintended Electrical Shock 1 1
Naturally Worn 1 1
Output Problem 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Unintended Ejection 1 1
Disassembly 1 1
Fracture 1 1
Device Damaged Prior to Use 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1
Inadequate User Interface 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 254 254
Insufficient Information 221 221
No Clinical Signs, Symptoms or Conditions 175 175
Foreign Body In Patient 103 103
Choking 89 89
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 55 55
Device Embedded In Tissue or Plaque 51 51
No Code Available 30 30
No Information 24 24
Pain 22 22
Discomfort 17 17
Vomiting 14 14
Swelling 11 11
Hemorrhage/Bleeding 11 11
Laceration(s) 9 9
Cough 9 9
No Consequences Or Impact To Patient 8 8
Injury 8 8
Hypersensitivity/Allergic reaction 6 6
Complaint, Ill-Defined 5 5
Reaction 5 5
Anxiety 4 4
Tooth Fracture 4 4
Inflammation 4 4
Irritation 4 4
Dyspnea 4 4
Tissue Damage 4 4
Burning Sensation 3 3
Rash 3 3
No Patient Involvement 3 3
Needle Stick/Puncture 3 3
Unspecified Tissue Injury 3 3
Unspecified Infection 3 3
Numbness 3 3
Sensitivity of Teeth 3 3
Sore Throat 2 2
Malaise 2 2
Unspecified Gastrointestinal Problem 2 2
Patient Problem/Medical Problem 2 2
Respiratory Distress 2 2
Emotional Changes 2 2
Abscess 2 2
Itching Sensation 2 2
High Blood Pressure/ Hypertension 1 1
Hemorrhage, Cerebral 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abrasion 1 1
Achalasia 1 1
Airway Obstruction 1 1
Anaphylactic Shock 1 1
Asthma 1 1
Burn(s) 1 1
Erythema 1 1
Eye Injury 1 1
Foreign Body Sensation in Eye 1 1
Headache 1 1
Hemoptysis 1 1
Skin Discoloration 1 1
Suffocation 1 1
Nausea 1 1
Perforation 1 1
Tingling 1 1
Ulceration 1 1
Tachycardia 1 1
Thrombosis 1 1
Thrombus 1 1
Hypervolemia 1 1
Dysuria 1 1
Post Traumatic Wound Infection 1 1
Sleep Dysfunction 1 1
Chemical Exposure 1 1
Injection Site Reaction 1 1
Stomatitis 1 1
Depression 1 1
Pharyngitis 1 1
Anaphylactoid 1 1
Discharge 1 1
Collapse 1 1
Coma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
2 Fridababy LLC II Jan-30-2020
3 Norwex Usa Inc II Feb-26-2015
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