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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sound, urethral, metal or plastic
Product CodeFBX
Regulation Number 876.5520
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2021 3 3
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Corroded 10 10
Adverse Event Without Identified Device or Use Problem 1 1
Device Unsafe to Use in Environment 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
Urinary Retention 1 1
No Known Impact Or Consequence To Patient 1 1

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