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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gauze/sponge, internal
Product CodeEFQ
Device Class Unclassified

MDR Year MDR Reports MDR Events
2019 5 5
2020 8 8
2021 6 6
2022 6 6
2023 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Component Missing 4 4
Detachment of Device or Device Component 3 3
Material Frayed 3 3
Material Integrity Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Remove 2 2
Unraveled Material 2 2
Packaging Problem 2 2
Protective Measures Problem 1 1
Insufficient Information 1 1
Device Fell 1 1
Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Contamination /Decontamination Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of or Failure to Bond 1 1
Break 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 6 6
Unspecified Infection 6 6
Foreign Body In Patient 4 4
Adhesion(s) 1 1
Itching Sensation 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 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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