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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device 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
2014 1 1
2017 2 2
2018 2 2
2019 3 3
2021 4 4
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Misassembly by Users 1 1
Physical Resistance/Sticking 1 1
Malposition of Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Break 1 1
Detachment Of Device Component 1 1
Entrapment of Device 1 1
Leak/Splash 1 1
Use of Device Problem 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 2 2
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Unspecified Gastrointestinal Problem 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Pain 1 1
Ulceration 1 1
Obstruction/Occlusion 1 1

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