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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, injection
Product CodeFGY
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2019 8 8
2020 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Fracture 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Detachment of Device or Device Component 2 2
Physical Resistance/Sticking 1 1
Leak/Splash 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Foreign Body In Patient 3 3
No Known Impact Or Consequence To Patient 2 2
Pain 2 2
Necrosis 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hobbs Medical, Inc. II Oct-07-2022
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