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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bag, urine collection, leg, for external use, non-sterile
Definition Urine collector and accessories; see product code FAQ.
Product CodeNNW
Regulation Number 876.5250
Device Class 1

MDR Year MDR Reports MDR Events
2018 4 4
2020 1 1
2021 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 2 2
Insufficient Information 2 2
Missing Information 1 1
Patient-Device Incompatibility 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Contamination 1 1
Restricted Flow rate 1 1
No Device Output 1 1
Defective Component 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erythema 1 1
Pain 1 1
Urinary Tract Infection 1 1
No Consequences Or Impact To Patient 1 1
Anaphylactoid 1 1
Pressure Sores 1 1
Reaction 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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