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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
2021 6 6
2022 6 6
2023 10 10
2024 8 8
2025 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 39 39
Material Frayed 7 7
Detachment of Device or Device Component 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Peeled/Delaminated 3 3
Material Disintegration 3 3
Extra Components 3 3
Break 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Fragmentation 2 2
Unraveled Material 2 2
Packaging Problem 2 2
Separation Problem 1 1
Entrapment of Device 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Device Fell 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Degraded 1 1
Component Missing 1 1
Protective Measures Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
Insufficient Information 18 18
Unspecified Infection 6 6
Foreign Body In Patient 3 3
Hypersensitivity/Allergic reaction 1 1

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