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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
Rupture 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Chorioamnionitis 2 2
Bradycardia 2 2
Abdominal Cramps 2 2
Abdominal Distention 2 2
Asystole 2 2
Insufficient Information 1 1
Low Blood Pressure/ Hypotension 1 1
Urinary Retention 1 1
Cervical Changes 1 1

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