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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device amnioscope, transabdominal (fetoscope) (and accessories)
Product CodeHFA
Regulation Number 884.1600
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2022 4 4
2023 1 1
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Output Problem 1 1
Lack of Effect 1 1
Difficult or Delayed Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hematoma 5 5
Hemorrhage/Bleeding 5 5
High Blood Pressure/ Hypertension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Rupture 3 3
Chorioamnionitis 2 2
Abdominal Cramps 2 2
Abdominal Distention 2 2
Bradycardia 2 2
Asystole 2 2
Urinary Retention 1 1
Insufficient Information 1 1
Cervical Changes 1 1
Low Blood Pressure/ Hypotension 1 1

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