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TPLC
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show TPLC since
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2019
2020
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Device
needle, assisted reproduction
Product Code
MQE
Regulation Number
884.6100
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALLWIN MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K190590
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum
...
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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