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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device gauze/sponge, internal
Product CodeEFQ
Device Class Unclassified

MDR Year MDR Reports MDR Events
2016 53 53
2017 8 8
2018 7 7
2019 5 5
2020 8 8
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 11 11
Incorrect Device Or Component Shipped 10 10
Material Frayed 9 9
Material Fragmentation 8 8
Device Operates Differently Than Expected 6 6
Incomplete or Missing Packaging 5 5
Packaging Problem 5 5
Material Separation 5 5
Device Contamination with Chemical or Other Material 5 5
Component Missing 4 4
Difficult to Remove 3 3
Torn Material 3 3
Detachment of Device or Device Component 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Detachment Of Device Component 2 2
Product Quality Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Break 2 2
Material Disintegration 1 1
Loss of or Failure to Bond 1 1
Shelf Life Exceeded 1 1
Metal Shedding Debris 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Protective Measures Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Failure to Obtain Sample 1 1
Contamination /Decontamination Problem 1 1
Component Falling 1 1
Contamination 1 1
Entrapment of Device 1 1
Flaked 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 50 50
No Information 8 8
No Patient Involvement 7 7
No Consequences Or Impact To Patient 7 7
Foreign Body In Patient 5 5
Staphylococcus Aureus 2 2
Skin Erosion 1 1
Skin Irritation 1 1
Abrasion 1 1
Insufficient Information 1 1
Adhesion(s) 1 1
Itching Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Surgical Company II May-26-2016
2 ROi CPS LLC II Dec-28-2020
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