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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


Premarket Reviews
ManufacturerDecision
MILLIKEN HEALTHCARE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
QUICK-MED TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 4 4
2016 5 5
2017 9 9
2018 21 21
2019 13 13
2020 26 26
2021 13 13
2022 4 4
2023 6 6
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 19 19
Material Fragmentation 15 15
Contamination /Decontamination Problem 14 14
Device Contamination with Chemical or Other Material 11 11
Material Frayed 9 9
Material Integrity Problem 8 8
Contamination 4 4
Device Reprocessing Problem 3 3
Material Discolored 3 3
Device Operates Differently Than Expected 3 3
Incomplete or Missing Packaging 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Failure to Clean Adequately 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Flaked 2 2
Fluid/Blood Leak 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Component Falling 1 1
Degraded 1 1
Difficult to Insert 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1
Device Slipped 1 1
Problem with Sterilization 1 1
Sticking 1 1
Defective Component 1 1
Physical Property Issue 1 1
No Apparent Adverse Event 1 1
Physical Resistance/Sticking 1 1
Device Packaging Compromised 1 1
Difficult to Open or Remove Packaging Material 1 1
Failure to Advance 1 1
Failure to Obtain Sample 1 1
Detachment of Device or Device Component 1 1
Human Factors Issue 1 1
Improper Flow or Infusion 1 1
Device Contaminated During Manufacture or Shipping 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 21 21
No Consequences Or Impact To Patient 13 13
No Information 12 12
Foreign Body In Patient 11 11
No Patient Involvement 5 5
Post Operative Wound Infection 3 3
Missing Value Reason 3 3
Insufficient Information 3 3
Not Applicable 2 2
Local Reaction 2 2
Therapeutic Effects, Unexpected 2 2
Unspecified Infection 1 1
Inflammation 1 1
Rash 1 1
Foreign Body Embolism 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Surgical Company II May-26-2016
2 Coloplast Corp Skin Care Div III Sep-04-2009
3 Medical Action Industries Inc II May-31-2018
4 Medline Industries Inc II Jul-16-2021
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