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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
KITAZATO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KITAZATO MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM A. COOK AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM A. COOK AUSTRALIA PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILLIAN A. COOK AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG HORIZON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2016 18 18
2017 3 3
2018 5 5
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 39 39
Dull, Blunt 19 19
Insufficient Information 8 8
Physical Property Issue 2 2
Device Operates Differently Than Expected 2 2
Break 2 2
Entrapment of Device 2 2
Unknown (for use when the device problem is not known) 1 1
Defective Component 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Collapse 1 1
Corroded 1 1
Structural Problem 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 29 29
Blood Loss 20 20
Intra-Abdominal Hemorrhage 8 8
No Clinical Signs, Symptoms or Conditions 8 8
Unspecified Infection 5 5
Abdominal Pain 3 3
Abscess 2 2
Urinary Retention 2 2
Hematuria 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Insufficient Information 1 1
Hospitalization required 1 1
No Patient Involvement 1 1
Aspiration/Inhalation 1 1
Pain 1 1

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