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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheters, salpingography
Product CodeMOV
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2018 2 2
2019 1 1
2020 2 2
2021 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 4 4
Peeled/Delaminated 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Operates Differently Than Expected 1 1
Break 1 1
Detachment Of Device Component 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
No Code Available 3 3
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 2 2
Foreign body, removal of 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Aug-22-2016
2 Cook Women'S Health II Mar-15-2010
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