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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device short-term intravascular filter catheter
Definition For short-term prevention of pulmonary embolism (PE)
Product CodePNS
Regulation Number 870.3375
Device Class 2

MDR Year MDR Reports MDR Events
2021 4 4
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Expulsion 1 1
Material Fragmentation 1 1
Device Dislodged or Dislocated 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Post Operative Wound Infection 6 6
No Clinical Signs, Symptoms or Conditions 4 4

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