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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, vessel, surgical
Product CodeDWP
Regulation Number 870.4475
Device Class 2


Premarket Reviews
ManufacturerDecision
FEHLING SURGICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FETZER MEDICAL GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
GEOMED MEDIZIN-TECHNIK GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMED INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS LIFE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 10 10
2015 25 25
2016 18 18
2017 34 34
2018 29 31
2019 5 5
2020 4 4
2021 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 111 113
Adverse Event Without Identified Device or Use Problem 4 4
Break 4 4
Unsealed Device Packaging 2 2
Particulates 2 2
Product Quality Problem 2 2
Packaging Problem 2 2
Device Operates Differently Than Expected 2 2
Material Twisted/Bent 1 1
Sticking 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 104 104
No Known Impact Or Consequence To Patient 12 14
No Consequences Or Impact To Patient 6 6
No Clinical Signs, Symptoms or Conditions 3 3
Injury 2 2
Atherosclerosis 1 1
Erosion 1 1
Tissue Damage 1 1
Vascular Dissection 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-05-2024
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