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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
2017 9 9
2018 21 21
2019 13 13
2020 26 26
2021 13 13
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 18 18
Contamination /Decontamination Problem 14 14
Material Fragmentation 13 13
Device Contamination with Chemical or Other Material 10 10
Material Frayed 9 9
Material Integrity Problem 3 3
Contamination 3 3
Incomplete or Missing Packaging 3 3
Device Reprocessing Problem 3 3
Material Discolored 2 2
Failure to Clean Adequately 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Flaked 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Difficult to Insert 1 1
Component Falling 1 1
Entrapment of Device 1 1
Degraded 1 1
Device Slipped 1 1
Detachment of Device or Device Component 1 1
Physical Property Issue 1 1
No Apparent Adverse Event 1 1
Product Quality Problem 1 1
Sticking 1 1
Defective Component 1 1
Failure to Advance 1 1
Physical Resistance/Sticking 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Disintegration 1 1
Problem with Sterilization 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 33 33
No Clinical Signs, Symptoms or Conditions 17 17
No Consequences Or Impact To Patient 11 11
Foreign Body In Patient 7 7
No Information 7 7
No Patient Involvement 5 5
Post Operative Wound Infection 3 3
Missing Value Reason 3 3
Not Applicable 2 2
Local Reaction 2 2
Inflammation 1 1
Unspecified Infection 1 1
Rash 1 1
Foreign Body Embolism 1 1
Insufficient Information 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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