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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spatula, cervical, cytological
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeHHT
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2020 3 3
2023 5 5
2024 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Patient-Device Incompatibility 1 1
Insufficient Information 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
No Clinical Signs, Symptoms or Conditions 4 4
Foreign Body In Patient 3 3
Syncope/Fainting 1 1
Burning Sensation 1 1
Discomfort 1 1
Pain 1 1
Laceration(s) 1 1
Reaction 1 1
Device Embedded In Tissue or Plaque 1 1
Ambulation Difficulties 1 1

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