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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ring, teething, non-fluid filled
Product CodeMEF
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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