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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
2018 7 7
2019 5 5
2020 8 8
2021 6 6
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 5 5
Packaging Problem 4 4
Material Separation 4 4
Material Integrity Problem 3 3
Component Missing 3 3
Material Frayed 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Fragmentation 2 2
Difficult to Remove 2 2
Protective Measures Problem 1 1
Material Disintegration 1 1
Device Fell 1 1
Detachment Of Device Component 1 1
Improper or Incorrect Procedure or Method 1 1
Device Contamination with Chemical or Other Material 1 1
Entrapment of Device 1 1
Flaked 1 1
Unraveled Material 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Loss of or Failure to Bond 1 1
Break 1 1
Insufficient Information 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
Foreign Body In Patient 5 5
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 2 2
Unspecified Infection 2 2
Itching Sensation 1 1
No Patient Involvement 1 1
Adhesion(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ROi CPS LLC II Dec-28-2020
2 Steris Corporation II May-20-2022
3 TELEFLEX LLC II Dec-28-2022
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