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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 2 2

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
Burst Container or Vessel 2 2
Break 2 2
Appropriate Term/Code Not Available 2 2
Leak/Splash 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Use of Device Problem 1 1
Positioning Failure 1 1
Structural Problem 1 1
Inflation Problem 1 1
Material Rupture 1 1
Material Separation 1 1
Incomplete or Missing Packaging 1 1
Entrapment of Device 1 1
Device Damaged Prior to Use 1 1
Expiration Date Error 1 1
Inaccurate Information 1 1
Inadequate or Insufficient Training 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Blood Loss 1 1

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