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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tampon, menstrual, scented, deodorized
Product CodeHIL
Regulation Number 884.5460
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 12 12
2021 7 7
2022 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 11 11
Adverse Event Without Identified Device or Use Problem 9 9
No Apparent Adverse Event 6 6
Material Separation 3 3
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Malposition of Device 1 1
Detachment of Device or Device Component 1 1
Degraded 1 1
Entrapment of Device 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 13 13
Device Embedded In Tissue or Plaque 5 5
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 2 2
Bacterial Infection 2 2
Unspecified Infection 1 1
Menstrual Irregularities 1 1
Pain 1 1
Local Reaction 1 1
Abnormal Vaginal Discharge 1 1
Burning Sensation 1 1
Skin Inflammation/ Irritation 1 1
No Known Impact Or Consequence To Patient 1 1

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