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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 9 9

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 Operates Differently Than Expected 3 3
Device Reprocessing Problem 3 3
Incomplete or Missing Packaging 3 3
Material Discolored 3 3
Material Disintegration 2 2
Flaked 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Failure to Clean Adequately 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Sticking 1 1
Failure to Advance 1 1
Component Falling 1 1
Fluid/Blood Leak 1 1
Device Slipped 1 1
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Open or Remove Packaging Material 1 1
Physical Resistance/Sticking 1 1
Entrapment of Device 1 1
Physical Property Issue 1 1
Failure to Obtain Sample 1 1
Defective Component 1 1
Human Factors Issue 1 1
Degraded 1 1
Difficult to Insert 1 1
Device Packaging Compromised 1 1
Use of Device Problem 1 1
Improper Flow or Infusion 1 1
Problem with Sterilization 1 1
Delivered as Unsterile Product 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 24 24
No Consequences Or Impact To Patient 13 13
No Information 12 12
Foreign Body In Patient 12 12
No Patient Involvement 5 5
Post Operative Wound Infection 3 3
Insufficient Information 3 3
Missing Value Reason 3 3
Not Applicable 2 2
Local Reaction 2 2
Therapeutic Effects, Unexpected 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 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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