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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, assisted reproduction
Product CodeMQE
Regulation Number 884.6100
Device Class 2


Premarket Reviews
ManufacturerDecision
SHENZHEN VITAVITRO BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG HORIZON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 2 2
2023 37 37
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 47 47
Insufficient Information 7 7
Dull, Blunt 6 6
Material Disintegration 2 2
Scratched Material 2 2
Collapse 1 1
Defective Component 1 1
Defective Device 1 1
Material Twisted/Bent 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 39 39
No Clinical Signs, Symptoms or Conditions 13 13
Intra-Abdominal Hemorrhage 8 8
Hematuria 1 1
Urinary Retention 1 1
Insufficient Information 1 1

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