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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enema kit
Regulation Description Enema kit.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeFCE
Regulation Number 876.5210
Device Class 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 2 2
2019 3 3
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 1 1
Entrapment of Device 1 1
Leak/Splash 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Malposition of Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Misassembly by Users 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 4 4
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Ulceration 1 1
Obstruction/Occlusion 1 1

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