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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
2016 1 1
2017 1 1
2018 14 14
2019 4 4
2020 1 1
2022 3 3
2023 17 17
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 12 12
Device Handling Problem 12 12
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
Break 2 2
Burst Container or Vessel 2 2
Positioning Failure 1 1
Entrapment of Device 1 1
Flaked 1 1
Material Fragmentation 1 1
Inflation Problem 1 1
Difficult to Insert 1 1
Inadequate Instructions for Healthcare Professional 1 1
Leak/Splash 1 1
Incomplete or Missing Packaging 1 1
Device Damaged Prior to Use 1 1
Material Rupture 1 1
Inadequate or Insufficient Training 1 1
Use of Device Problem 1 1
Inaccurate Information 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 7 7
No Patient Involvement 6 6
Tissue Damage 4 4
Foreign Body In Patient 3 3
Injury 2 2
Blood Loss 1 1

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