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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filiform and filiform follower
Product CodeFBW
Regulation Number 876.5520
Device Class 1

MDR Year MDR Reports MDR Events
2018 14 14
2019 4 4
2020 1 1
2021 4 4
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 9 9
Dull, Blunt 6 6
Component Missing 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Material Deformation 2 2
Appropriate Term/Code Not Available 2 2
Sharp Edges 1 1
Inaccurate Information 1 1
Insufficient Information 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Material Too Rigid or Stiff 1 1
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
Break 1 1
Burst Container or Vessel 1 1
Corroded 1 1
Entrapment of Device 1 1
Flaked 1 1
Failure to Fold 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Inadequate Instructions for Healthcare Professional 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11 11
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 6 6
No Patient Involvement 5 5
Tissue Damage 4 4
Foreign Body In Patient 3 3
Injury 2 2
Blood Loss 1 1
Uterine Perforation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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