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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fetal head elevator
Regulation Description Fetal head elevator.
Definition To elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery.
Product CodePWB
Regulation Number 884.4350
Device Class 2


Premarket Reviews
ManufacturerDecision
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 5 5
2023 3 3
2024 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Output Problem 2 2
Insufficient Information 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Uterine Perforation 3 3
Rupture 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Fetal Distress 1 1
Hematoma 1 1

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