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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
2021 4 4
2023 1 1
2024 10 10
2025 2 2
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 8 8
Improper or Incorrect Procedure or Method 3 3
Entrapment of Device 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 14 14
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Gastrointestinal Problem 1 1
Pain 1 1

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