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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fiber, medical, absorbent
Regulation Description Medical absorbent fiber.
Product CodeFRL
Regulation Number 880.5300
Device Class 1

MDR Year MDR Reports MDR Events
2021 13 14
2022 4 4
2023 6 6
2024 9 9
2025 4 4
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 6 6
Material Separation 6 6
Contamination 5 5
Material Frayed 3 3
Material Discolored 3 3
Contamination /Decontamination Problem 2 2
Delivered as Unsterile Product 2 2
Device Contamination with Chemical or Other Material 2 3
Entrapment of Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Material Disintegration 1 1
Defective Component 1 1
Material Fragmentation 1 1
Use of Device Problem 1 1
Improper Flow or Infusion 1 1
Problem with Sterilization 1 1
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Foreign Body In Patient 8 8
Insufficient Information 4 4
Local Reaction 2 3
Unspecified Infection 1 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Inflammation 1 1
Blister 1 1
Rash 1 2
Needle Stick/Puncture 1 1
Pain 1 1
Scar Tissue 1 1
Eye Infections 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II Jul-16-2021
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