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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
Product CodeFRL
Regulation Number 880.5300
Device Class 1

MDR Year MDR Reports MDR Events
2018 21 21
2019 13 13
2020 26 26
2021 13 13
2022 4 4
2023 6 6
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 18 18
Contamination /Decontamination Problem 14 14
Material Fragmentation 14 14
Device Contamination with Chemical or Other Material 8 8
Material Integrity Problem 6 6
Material Frayed 5 5
Contamination 4 4
Incomplete or Missing Packaging 3 3
Device Reprocessing Problem 3 3
Material Disintegration 2 2
Failure to Clean Adequately 2 2
Material Discolored 2 2
Flaked 2 2
Device Slipped 1 1
Device Contaminated During Manufacture or Shipping 1 1
Entrapment of Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Physical Resistance/Sticking 1 1
Physical Property Issue 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Degraded 1 1
Difficult to Insert 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
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Failure to Advance 1 1
Device Operates Differently Than Expected 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 29 29
No Clinical Signs, Symptoms or Conditions 24 24
No Consequences Or Impact To Patient 11 11
Foreign Body In Patient 10 10
No Information 7 7
Post Operative Wound Infection 3 3
Insufficient Information 3 3
Missing Value Reason 3 3
Local Reaction 2 2
No Patient Involvement 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
Foreign Body Embolism 1 1
Pain 1 1
Scar Tissue 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medical Action Industries Inc II May-31-2018
2 Medline Industries Inc II Jul-16-2021
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