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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
2020 26 26
2021 13 13
2022 4 4
2023 6 6
2024 9 9
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 12 12
Contamination /Decontamination Problem 9 9
Material Fragmentation 8 8
Material Integrity Problem 6 6
Material Frayed 4 4
Device Contamination with Chemical or Other Material 4 4
Contamination 3 3
Material Discolored 2 2
Entrapment of Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Material Disintegration 1 1
Defective Component 1 1
Degraded 1 1
Use of Device Problem 1 1
Improper Flow or Infusion 1 1
Problem with Sterilization 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Delivered as Unsterile Product 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
No Known Impact Or Consequence To Patient 13 13
Foreign Body In Patient 8 8
No Consequences Or Impact To Patient 5 5
Insufficient Information 3 3
Local Reaction 2 2
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Inflammation 1 1
Blister 1 1
Rash 1 1
No Patient Involvement 1 1
Foreign Body Embolism 1 1
Pain 1 1
Scar Tissue 1 1
Missing Value Reason 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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