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TPLC
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Device
ring, teething, non-fluid filled
Product Code
MEF
Regulation Number
872.5550
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
10
10
2019
14
14
2020
1
1
2021
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
6
6
Detachment of Device or Device Component
5
5
Product Quality Problem
3
3
Material Fragmentation
2
2
Protective Measures Problem
2
2
Scratched Material
1
1
Device Fell
1
1
Component Falling
1
1
Labelling, Instructions for Use or Training Problem
1
1
Peeled/Delaminated
1
1
Material Puncture/Hole
1
1
Material Separation
1
1
Problem with Sterilization
1
1
Cut In Material
1
1
Patient-Device Incompatibility
1
1
Device Markings/Labelling Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Material Integrity Problem
1
1
Material Protrusion/Extrusion
1
1
Material Twisted/Bent
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
15
15
Choking
3
3
Foreign Body In Patient
3
3
Dyspnea
2
2
No Consequences Or Impact To Patient
2
2
Injury
1
1
Strangulation
1
1
Vomiting
1
1
No Clinical Signs, Symptoms or Conditions
1
1
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