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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
ALLWIN MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG HORIZON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 1 1
2022 2 2
2023 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 33 33
Insufficient Information 7 7
Dull, Blunt 4 4
Break 2 2
Entrapment of Device 2 2
Defective Component 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Collapse 1 1
Corroded 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 27 27
Intra-Abdominal Hemorrhage 8 8
No Clinical Signs, Symptoms or Conditions 8 8
Device Embedded In Tissue or Plaque 2 2
Urinary Retention 2 2
Hematuria 2 2
No Patient Involvement 1 1
Insufficient Information 1 1

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