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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dislodger, stone, flexible
Product CodeFGO
Regulation Number 876.4680
Device Class 2

MDR Year MDR Reports MDR Events
2019 25 25
2020 19 19
2021 14 14
2022 18 18
2023 14 14
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 33 33
Peeled/Delaminated 31 31
Difficult to Open or Close 18 18
Break 16 16
Material Deformation 5 5
Material Split, Cut or Torn 5 5
Adverse Event Without Identified Device or Use Problem 3 3
Packaging Problem 2 2
Device Fell 2 2
Material Twisted/Bent 2 2
Difficult to Remove 2 2
Retraction Problem 1 1
Shipping Damage or Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Device 1 1
Degraded 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Difficult to Advance 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 47
No Consequences Or Impact To Patient 35 35
No Known Impact Or Consequence To Patient 7 7
Foreign Body In Patient 4 4
Insufficient Information 4 4
No Code Available 1 1
Unspecified Kidney or Urinary Problem 1 1
Injury 1 1
Hematuria 1 1
Myocardial Infarction 1 1
Urinary Tract Infection 1 1

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