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TPLC
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show TPLC since
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2024
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Device
light, operating, dental
Product Code
EAZ
Regulation Number
872.4630
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
13
13
2015
13
13
2016
9
9
2017
11
11
2018
10
10
2019
4
4
2020
3
3
2021
8
8
2023
2
2
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Component Falling
27
27
Device Fell
15
15
Installation-Related Problem
13
13
Detachment Of Device Component
8
8
Break
7
7
Device Maintenance Issue
4
4
Mechanical Problem
4
4
Detachment of Device or Device Component
3
3
Misassembly During Maintenance/Repair
2
2
Device Handling Problem
2
2
Use of Device Problem
2
2
Defective Device
2
2
Burst Container or Vessel
1
1
Unintended Collision
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Contusion
11
11
No Consequences Or Impact To Patient
10
10
No Known Impact Or Consequence To Patient
10
10
No Clinical Signs, Symptoms or Conditions
8
8
No Patient Involvement
7
7
Laceration(s)
6
6
Swelling
5
5
Burn(s)
5
5
Bruise/Contusion
4
4
Injury
4
4
Superficial (First Degree) Burn
3
3
Pain
3
3
Burning Sensation
2
2
Concussion
1
1
Spinal Column Injury
1
1
Abrasion
1
1
Bone Fracture(s)
1
1
Brain Injury
1
1
Neck Pain
1
1
Suture Abrasion
1
1
Burn, Thermal
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Dental Equipment LLC
II
Jul-15-2011
2
Pelton & Crane / Marus / DCI Equipment / KaVo
II
Mar-28-2016
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