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TPLC
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show TPLC since
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Device
toothbrush, powered
Product Code
JEQ
Regulation Number
872.6865
Device Class
1
Premarket Reviews
Manufacturer
Decision
THE PROCTER & GAMBLE COMPANY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
385
385
2020
433
433
2021
551
551
2022
611
611
2023
567
567
2024
405
405
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
750
750
Break
646
646
No Apparent Adverse Event
578
578
Loose or Intermittent Connection
255
255
Insufficient Information
160
160
Patient Device Interaction Problem
113
113
Mechanical Problem
97
97
Device Slipped
94
94
Overheating of Device
83
83
Material Fragmentation
79
79
Electrical /Electronic Property Problem
67
67
Fire
65
65
Material Separation
64
64
Connection Problem
61
61
Device Fell
57
57
Temperature Problem
45
45
Arcing
26
26
Smoking
24
24
Naturally Worn
24
24
Adverse Event Without Identified Device or Use Problem
18
18
Product Quality Problem
17
17
Device Dislodged or Dislocated
16
16
Explosion
16
16
Crack
13
13
Noise, Audible
13
13
Thermal Decomposition of Device
11
11
Device Emits Odor
11
11
Vibration
10
10
Defective Device
9
9
Output Problem
9
9
Fitting Problem
9
9
Sparking
9
9
Appropriate Term/Code Not Available
8
8
Degraded
8
8
Melted
8
8
Separation Problem
7
7
Battery Problem
6
6
Burst Container or Vessel
6
6
Sharp Edges
6
6
Component Missing
5
5
Excessive Heating
5
5
Charging Problem
5
5
Material Protrusion/Extrusion
5
5
Unstable
4
4
Leak/Splash
4
4
Material Split, Cut or Torn
4
4
Material Disintegration
4
4
Patient-Device Incompatibility
4
4
Material Integrity Problem
4
4
Structural Problem
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1708
1708
No Consequences Or Impact To Patient
342
342
Unspecified Tissue Injury
173
173
Tooth Fracture
134
134
No Known Impact Or Consequence To Patient
102
102
Pain
94
94
Laceration(s)
92
92
Hemorrhage/Bleeding
82
82
Foreign Body In Patient
80
80
Choking
76
76
Insufficient Information
70
70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
50
50
Injury
43
43
Burn(s)
22
22
Discomfort
20
20
No Patient Involvement
14
14
Electric Shock
11
11
Abrasion
9
9
Skin Inflammation/ Irritation
7
7
Device Embedded In Tissue or Plaque
6
6
Erosion
6
6
Cough
6
6
Swelling/ Edema
6
6
No Code Available
6
6
Patient Problem/Medical Problem
5
5
Sensitivity of Teeth
4
4
Tinnitus
4
4
Bruise/Contusion
3
3
Itching Sensation
3
3
Chemical Exposure
3
3
Superficial (First Degree) Burn
3
3
Vomiting
3
3
Dyspnea
3
3
Skin Discoloration
2
2
Irritation
2
2
Bone Fracture(s)
2
2
Tissue Damage
2
2
Caustic/Chemical Burns
2
2
Abdominal Pain
2
2
Scar Tissue
2
2
Stomatitis
1
1
Airway Obstruction
1
1
Headache
1
1
Hypoesthesia
1
1
Irritability
1
1
Sore Throat
1
1
Unspecified Infection
1
1
Skin Infection
1
1
Partial thickness (Second Degree) Burn
1
1
Anxiety
1
1
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