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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, uterine contraction, external (for use in clinic)
Regulation Description External uterine contraction monitor and accessories.
Product CodeHFM
Regulation Number 884.2720
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2022 2 2
2023 3 3
2024 1 1
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 3 3
Insufficient Information 2 2
No Audible Prompt/Feedback 2 2
Low Readings 2 2
Device Alarm System 1 1
Unable to Obtain Readings 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Incorrect Measurement 1 1
Defective Alarm 1 1
Device Reprocessing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Blister 2 2
Encephalopathy 1 1
Local Reaction 1 1
Insufficient Information 1 1
Hypoxia 1 1

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