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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
2021 6 6
2022 6 6
2023 10 10
2024 8 8
2025 51 51
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 45 45
Material Frayed 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Extra Components 4 4
Material Disintegration 3 3
Material Fragmentation 3 3
Unraveled Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Break 1 1
Separation Problem 1 1
Nonstandard Device 1 1
Protective Measures Problem 1 1
Insufficient Device Problem Information 1 1
Material Integrity Problem 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 66 66
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 AMD Medicom Inc. II Jun-16-2026
2 Steris Corporation II May-20-2022
3 TELEFLEX LLC II Jul-01-2026
4 TELEFLEX LLC II Dec-28-2022
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