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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transducer, pressure, intrauterine
Regulation Description Intrauterine pressure monitor and accessories.
Product CodeHFN
Regulation Number 884.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 3 3
2023 1 1
2024 4 4
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate User Interface 1 1
Insufficient Device Problem Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Hemorrhage/Blood Loss/Bleeding 2 2
Uterine Perforation 2 2
Head Injury 2 2
Laceration(s) 2 2
Bacterial Infection 1 1
Thrombosis/Thrombus 1 1
Rupture 1 1
Fetal Distress 1 1
Bruise/Contusion 1 1
Meningitis 1 1
Injury 1 1
Chorioamnionitis 1 1
Pressure Sore/Ulcer 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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