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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device uterine electromyographic monitor
Definition The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.
Product CodeOSP
Regulation Number 884.2720
Device Class 2


Premarket Reviews
ManufacturerDecision
MONICA HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
MONICA HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
NEMO HEALTHCARE BV
  SUBSTANTIALLY EQUIVALENT 1
OBMEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 2
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 1 1
2019 2 2
2020 1 1
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2 2
Device Sensing Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 1 1
Defective Alarm 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abrasion 1 1
Death 1 1
Skin Irritation 1 1
Discharge 1 1
Injury 1 1
Skin Tears 1 1
Diminished Pulse Pressure 1 1
Superficial (First Degree) Burn 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Mar-14-2018
2 MONICA HEALTHCARE LTD II May-25-2017
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