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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, cervical, synthetic, osmotic
Regulation Description Hygroscopic Laminaria cervical dilator.
Definition Cervical softening and dilation
Product CodePKN
Regulation Number 884.4260
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2022 2 2
2024 5 5
2025 3 3
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 4 4
Migration 4 4
Use of Device Problem 3 3
No Apparent Adverse Event 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Pelvic Inflammatory Disease 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Uterine Perforation 1 1
Chorioamnionitis 1 1
Infertility 1 1
Rupture 1 1
Discomfort 1 1
Unspecified Tissue Injury 1 1

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