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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent, bladder, fetal
Product CodeMPR
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2020 10 10
2021 1 1
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Off-Label Use 3 3
Separation Failure 2 2
Difficult to Advance 2 2
Insufficient Information 2 2
Migration or Expulsion of Device 1 1
Product Quality Problem 1 1
Migration 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
No Code Available 4 4
Insufficient Information 2 2
Abortion 2 2
Rupture 1 1
Bradycardia 1 1
Hemorrhage/Bleeding 1 1
Ascites 1 1
Spontaneous Abortion 1 1
Death, Intrauterine Fetal 1 1

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