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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ear irrigation 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 CodeOGQ
Regulation Number 880.6960
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2020 2 2
2021 2 2
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 1 1
Patient Device Interaction Problem 1 1
Break 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2 2
Tissue Damage 1 1
Rupture 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Hearing Loss 1 1
Unspecified Infection 1 1

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