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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cystometric gas (carbon-dioxide) on hydraulic device
Regulation Description Urodynamics measurement system.
Product CodeFAP
Regulation Number 876.1620
Device Class 2

MDR Year MDR Reports MDR Events
2024 2 2
2025 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 34 34
Detachment of Device or Device Component 5 5
Device Contaminated During Manufacture or Shipping 1 1
Air/Gas in Device 1 1
No Flow 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
Hyperglycemia 9 9
Hemorrhage/Bleeding 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Spes Medica II Jun-25-2021
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